Methods for delivering prosthetic valves to native heart valves

ABSTRACT

Representative embodiments of methods, apparatus, and systems used to deliver a prosthetic heart valve to a deficient valve are disclosed. In one embodiment, for instance, a support structure and an expandable prosthetic valve are delivered to a position on or adjacent to the surface of the outflow side of the aortic valve (the support structure defining a support-structure interior) via a delivery system. The expandable prosthetic valve is delivered into the aortic valve and into the support-structure interior. The expandable, prosthetic heart valve is expanded while the expandable prosthetic heart valve is in the support-structure interior and while the support structure is at the position on or adjacent to the surface of the outflow side of the aortic valve, thereby causing one or more native leaflets of the aortic valve to be frictionally secured between the support structure and the expanded prosthetic heart valve.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of U.S. patent application Ser. No.13/188,988, now U.S. Pat. No. 9,326,853, filed Jul. 22, 2011, whichclaims the benefit of U.S. Provisional Application No. 61/367,293, filedJul. 23, 2010, and U.S. Provisional Application No. 61/426,407, filedDec. 22, 2010, both of which are incorporated herein by reference.

FIELD

This application relates to methods, systems, and apparatus for safelyreplacing native heart valves with prosthetic heart valves.

BACKGROUND

Prosthetic heart valves have been used for many years to treat cardiacvalvular disorders. The native heart valves (such as the aortic,pulmonary, and mitral valves) serve critical functions in assuring theforward flow of an adequate supply of blood through the cardiovascularsystem. These heart valves can be rendered less effective by congenital,inflammatory, or infectious conditions. Such conditions can eventuallylead to serious cardiovascular compromise or death. For many years thedefinitive treatment for such disorders was the surgical repair orreplacement of the valve during open heart surgery, but such surgeriesare dangerous and prone to complication.

More recently a transvascular technique has been developed forintroducing and implanting a prosthetic heart valve using a flexiblecatheter in a manner that is less invasive than open heart surgery. Inthis technique, a prosthetic valve is mounted in a crimped state on theend portion of a flexible catheter and advanced through a blood vesselof the patient until the valve reaches the implantation site. The valveat the catheter tip is then expanded to its functional size at the siteof the defective native valve, such as by inflating a balloon on whichthe valve is mounted. Alternatively, the valve can have a resilient,self-expanding stent or frame that expands the valve to its functionalsize when it is advanced from a delivery sheath at the distal end of thecatheter.

Balloon-expandable valves are commonly used for treating heart valvestenosis, a condition in which the leaflets of a valve (e.g., an aorticvalve) become hardened with calcium. The hardened leaflets provide agood support structure on which the valve can be anchored within thevalve annulus. Further, the catheter balloon can apply sufficientexpanding force to anchor the frame of the prosthetic valve to thesurrounding calcified tissue. There are several heart conditions,however, that do not involve hardened valve leaflets but which are stilldesirably treated by valve replacement. For example, aorticinsufficiency (or aortic regurgitation) occurs when an aortic valve doesnot close properly, allowing blood to flow back into the left ventricle.One cause for aortic insufficiency is a dilated aortic annulus, whichprevents the aortic valve from closing tightly. In such cases, theleaflets are usually too soft to provide sufficient support for aballoon-expandable prosthetic valve. Additionally, the diameter of theaortic annulus may continue to vary over time, making it dangerous toinstall a prosthetic valve that is not reliably secured in the valveannulus. Mitral insufficiency (or mitral regurgitation) involves thesesame conditions but affects the mitral valve.

Self-expanding prosthetic valves are sometimes used for replacingdefective native valves with noncalcified leaflets. Self-expandingprosthetic valves, however, suffer from a number of significantdrawbacks. For example, once a self-expanding prosthetic valve is placedwithin the patient's defective heart valve (e.g., the aorta or mitralvalve), it continues to exert an outward force on the valve annulus.This continuous outward pressure can cause the valve annulus to dilatefurther, exacerbating the condition the valve was intended to treat.Additionally, when implanting a self-expanding valve, the outwardbiasing force of the valve's frame tends to cause the valve to beejected very quickly from the distal end of a delivery sheath. Thismakes delivery of the valve very difficult and dangerous to the patient.

The size of the prosthetic valve to be implanted into a patient can alsobe problematic when treating aortic or mitral insufficiency.Specifically, the size of a prosthetic valve used to treat aortic ormitral insufficiency is typically larger than a prosthetic valve used totreat aortic or mitral stenosis. This larger valve size makes thedelivery procedure much more difficult and dangerous to the patient.

Accordingly, there exists a need for improved methods, systems, andapparatus for delivering expandable prosthetic heart valves (e.g.,balloon-expandable prosthetic valves). Embodiments of the methods,systems, and apparatus desirably can be used to replace native heartvalves that do not have calcified leaflets (e.g., aortic valvessuffering from aortic insufficiency). Furthermore, embodiments of themethods, systems, and apparatus desirably enable precise and controlleddelivery of the prosthetic valves.

SUMMARY

Disclosed below are representative embodiments of methods, systems, andapparatus used to replace deficient native heart valves with prostheticheart valves. Embodiments of the disclosed methods, systems, andapparatus can be used, for example, to replace an aortic valve sufferingfrom aortic insufficiency or a mitral valve suffering from mitralinsufficiency. These embodiments are not limiting, however, as thedisclosed methods, systems, and apparatus can be more generally appliedto replace any heart valve.

In certain embodiments, for example, a support structure is delivered toa position on or adjacent to the surface of the outflow side of a nativeheart valve of a patient, the support structure defining asupport-structure interior. An expandable prosthetic heart valve isdelivered into the native heart valve and into the support-structureinterior. The expandable prosthetic heart valve can be expanded whilethe expandable prosthetic heart valve is in the support-structureinterior and while the support structure is at the position on oradjacent to the surface of the outflow side of the native heart valve,thereby causing one or more native leaflets of the native heart valve tobe frictionally secured between the support structure and the expandedprosthetic heart valve. The expandable prosthetic heart valve can bedelivered from the inflow or the outflow side of the native heart valve.In certain embodiments, the native heart valve is an aortic valve, andthe act of delivering the expandable prosthetic heart valve comprisesdelivering the prosthetic heart valve through the left ventricle of thepatient's heart. In other embodiments, the native heart valve is anaortic valve, and the act of delivering the expandable prosthetic heartvalve comprises delivering the prosthetic heart valve through thepatient's aorta. In particular embodiments, the native heart valve is anaortic valve, the support structure is a support stent, and the act ofdelivering the support structure comprises advancing a first catheterthrough the aortic arch of the patient so that a distal end of the firstcatheter is near the aortic valve of the patient (the first catheter atleast partially enclosing a stent-delivery catheter, an inner catheter,and the support stent in a compressed state) and advancing thestent-delivery catheter and the inner catheter through the firstcatheter, thereby causing the support stent to be deployed from thedistal end of the first catheter and to expand into a decompressedstate. In other particular embodiments, the native heart valve is amitral valve, the support structure is a support band, and the act ofdelivering the support structure comprises advancing a first loopdelivery catheter into the left ventricle of the patient so that a firstdistal end of the first loop delivery catheter extends around a firstportion of the chordae tendineae, advancing a second loop deliverycatheter into the left ventricle of the patient so that a second distalend of the second loop delivery catheter extends around a second portionof the chordae tendineae and so that the second distal end of the secondloop delivery is adjacent to the first distal end of the first loopdelivery catheter, advancing a support band material through an interiorof the first loop delivery catheter and an interior of the second loopdelivery catheter, attaching a locking member to portions of the supportband material, and advancing the locking member along the portions ofthe support band material and into the left ventricle of the patient,thereby forming the support band around the chordae tendineae. Incertain embodiments, the act of delivering the support structurecomprises guiding the support structure to the position on or adjacentto the surface of the outflow side of the native heart valve and into adesired orientation, wherein the desired orientation aligns peaks of thesupport structure with either the tips or the commissures of the one ormore native leaflets. In further embodiments, the support structure isdisconnected from at least a delivery catheter once the one or morenative leaflets of the native heart valve are frictionally securedbetween the support structure and the expanded prosthetic heart valve.The disconnecting can be performed by retracting an inner catheterrelative to a stent-delivery catheter, thereby retracting inner prongscoupled to the inner catheter from corresponding apertures in retainingarms of the support stent. Alternatively, the disconnecting can beperformed by cutting through material used to form the supportstructure, thereby releasing the support structure from a catheter. Incertain embodiments, the act of expanding the expandable prostheticheart valve comprises inflating a balloon of a balloon catheter, theexpandable prosthetic heart valve being disposed around the balloon ofthe balloon catheter.

In certain embodiments, for example, a support structure is delivered toa position on or adjacent to the surface of the outflow side of a nativeheart valve of a patient, the support structure defining asupport-structure interior. An expandable prosthetic heart valve isdelivered into the native heart valve and into the support-structureinterior. The expandable prosthetic heart valve can be expanded whilethe expandable prosthetic heart valve is in the support-structureinterior and while the support structure is at the position on oradjacent to the surface of the outflow side of the native heart valve,thereby causing one or more native leaflets of the native heart valve tobe frictionally secured between the support structure and the expandedprosthetic heart valve. The expandable prosthetic heart valve can bedelivered from the inflow or the outflow side of the native heart valve.In certain embodiments, the native heart valve is an aortic valve, andthe act of delivering the expandable prosthetic heart valve comprisesdelivering the prosthetic heart valve through the left ventricle of thepatient's heart. In other embodiments, the native heart valve is anaortic valve, and the act of delivering the expandable prosthetic heartvalve comprises delivering the prosthetic heart valve through thepatient's aorta. In particular embodiments, the native heart valve is anaortic valve, the support structure is a support stent, and the act ofdelivering the support structure comprises advancing a first catheterthrough the aortic arch of the patient so that a distal end of the firstcatheter is near the aortic valve of the patient (the first catheter atleast partially enclosing a stent-delivery catheter, an inner catheter,and the support stent in a compressed state) and advancing thestent-delivery catheter and the inner catheter through the firstcatheter, thereby causing the support stent to be deployed from thedistal end of the first catheter and to expand into a decompressedstate. In other particular embodiments, the native heart valve is amitral valve, the support structure is a support band, and the act ofdelivering the support structure comprises advancing a first loopdelivery catheter into the left ventricle of the patient so that a firstdistal end of the first loop delivery catheter extends around a firstportion of the chordae tendineae, advancing a second loop deliverycatheter into the left ventricle of the patient so that a second distalend of the second loop delivery catheter extends around a second portionof the chordae tendineae and so that the second distal end of the secondloop delivery is adjacent to the first distal end of the first loopdelivery catheter, advancing a support band material through an interiorof the first loop delivery catheter and an interior of the second loopdelivery catheter, attaching a locking member to portions of the supportband material, and advancing the locking member along the portions ofthe support band material and into the left ventricle of the patient,thereby forming the support band around the chordae tendineae. Incertain embodiments, the act of delivering the support structurecomprises guiding the support structure to the position on or adjacentto the surface of the outflow side of the native heart valve and into adesired orientation, wherein the desired orientation aligns peaks of thesupport structure with either the tips or the commissures of the one ormore native leaflets. In further embodiments, the support structure isdisconnected from at least a delivery catheter once the one or morenative leaflets of the native heart valve are frictionally securedbetween the support structure and the expanded prosthetic heart valve.The disconnecting can be performed by retracting an inner catheterrelative to a stent-delivery catheter, thereby retracting inner prongscoupled to the inner catheter from corresponding apertures in retainingarms of the support stent. Alternatively, the disconnecting can beperformed by cutting through material used to form the supportstructure, thereby releasing the support structure from a catheter. Incertain embodiments, the act of expanding the expandable prostheticheart valve comprises inflating a balloon of a balloon catheter, theexpandable prosthetic heart valve being disposed around the balloon ofthe balloon catheter.

In other exemplary methods disclosed herein, a guide catheter isadvanced through the aortic arch of a patient so that a distal end ofthe guide catheter is near the aortic valve of the patient. In theseembodiments, the guide catheter at least partially encloses astent-delivery catheter and a compressed support stent releasablyconnected to the stent-delivery catheter. The stent-delivery catheter isadvanced through the guide catheter, thereby causing the support stentto be deployed from the distal end of the guide catheter and to becomeuncompressed. The uncompressed support stent is positioned adjacent toor on a surface of the aortic side of the aortic valve such that theleaflets of the aortic valve are circumscribed by the uncompressedsupport stent. The uncompressed support stent can then be disconnectedfrom the stent-delivery catheter. In certain embodiments, to disconnectthe support stent from the stent-delivery catheter, an inner catheterpositioned in the interior of the stent-delivery catheter can beretracted, causing an inner prong attached to the inner catheter towithdraw from an aperture associated with the support stent, and/or atleast one prong attached to the stent-delivery catheter can bedisconnected from the support stent.

Other exemplary embodiments disclosed herein include apparatus forsecuring a prosthetic valve to a native heart valve. For example,certain embodiments comprise a support stent having an annular body thatdefines one or more peaks and one or more valleys along itscircumference. The support stent can be radially compressible and selfexpandable. The support stent can be sized such that it can bepositioned within the aorta of a patient at a location adjacent to theaortic valve and thereby circumscribe the aortic valve. The supportstent can further comprise at least one retaining arm comprises anaperture at or near a respective one of the peaks. In particularembodiments, the support stent is formed from a single annular member.In some embodiments, the support stent consists of three peaks and threevalleys. The shape formed by the three peaks and the three valleys canapproximate the shape of the leaflets of the aortic valve when theaortic valve is fully opened. In certain embodiments, a projection ofthe annular body onto a first plane is ring shaped or starfish shaped,and the annular body defines the one or more peaks and the one or morevalleys in a direction perpendicular to the first plane. For example,the annular body can be sinusoidal or saw-tooth shaped along itscircumference. Certain embodiments further comprise a stent deliverycatheter having an outer fork that includes one or more outer prongs. Atleast one of the outer prongs can comprise an aperture that is sized toreceive at least a portion of one of the retaining arms of the supportstent. An inner catheter can be positioned in an interior of thestent-delivery catheter and have an inner fork. The inner fork cancomprise one or more inner prongs, and at least one of the inner prongscan be insertable through the aperture of the one of the retaining armswhen the one of the retaining arms has been at least partially insertedthrough the aperture of a respective one of the outer prongs.

Other exemplary embodiments disclosed herein are systems for deliveringa support frame for securing a prosthetic valve in a patient's nativeheart valve. Exemplary embodiments of the system comprise a guidecatheter, a frame-delivery catheter positioned in the interior of theguide catheter, an inner catheter positioned in the interior of theframe-delivery catheter, and an expandable support frame positioned inthe interior of the guide catheter in a radially compressed state. Adistal end of the frame-delivery catheter can have an outer fork portionthat comprises a plurality of flexible outer prongs. A distal end of theinner catheter can have an inner fork portion that comprises a pluralityof flexible inner prongs. The expandable support frame can comprise aplurality of retaining arms, which can be releasably connected tocorresponding ones of the outer prongs of the outer fork portion andcorresponding ones of the inner prongs of the inner fork portion. Theexpandable support frame can be generally annular and comprise shapedportions configured to frictionally secure native leaflets of apatient's heart valve against an exterior surface of a prosthetic valvewhen the patient's heart valve has been replaced by the prostheticvalve. Alternatively, the expandable support frame can comprise a mainbody and a U-shaped lip that surrounds a bottom region of the supportframe, the U-shaped lip having a diameter that is greater than adiameter of the main body. In particular embodiments, the guidecatheter, frame-delivery catheter, and the inner catheter are axiallyslidable relative to one another. In some embodiments, the retainingarms of the expandable support frame comprise respective retaining armapertures through which the corresponding ones of the inner prongs areinserted. The corresponding ones of the outer prongs can comprise, forexample, respective outer prong apertures through which the respectiveretaining arms are inserted. In certain embodiments, the correspondingones of the outer prongs and the corresponding ones of the inner prongsof the inner fork portion are configured such that relative retractionof either the corresponding ones of the inner prongs or thecorresponding ones of the outer prongs causes release of the respectiveretaining arms.

Another disclosed embodiment is an apparatus comprising a support stenthaving an annular main body portion and a generally U-shaped rim portionat one end of the main body portion. The support stent of thisembodiment is radially compressible into a compressed state and selfexpandable into an uncompressed state. Furthermore, the rim portion hasa diameter that is greater than a diameter of the annular main bodyportion and that is sized so that an outer perimeter of the rim portionwill engage the walls surrounding the aortic valve of a patient when thesupport stent is positioned within the aorta of the patient at alocation adjacent to the aortic valve. In some embodiments, the supportstent is made of a shape-memory alloy. In certain embodiments, theannular main body portion is sinusoidal or saw-tooth shaped along itscircumference. In some embodiments, the rim portion is located around abottom region of the main body portion. In certain embodiments, thesupport stent is made of multiple elements forming a criss-crosspattern. In particular embodiments, the apparatus further comprises atleast one retaining arm at or near a top region of the main bodyportion.

In another disclosed embodiment, a distal end of a first deliverycatheter is advanced into the left ventricle of a patient so that adistal portion of the first delivery catheter substantiallycircumscribes a first half of the patient's chordae tendineae. A distalend of a second delivery catheter is advanced into the left ventricle ofthe patient so that a distal portion of the second delivery cathetersubstantially circumscribes a second half of the patient's chordaetendineae and so that a distal end of the second delivery cathetercontacts a distal end of the first delivery catheter, thereby forming adelivery catheter junction. A support band material is advanced throughone of the first delivery catheter or the second delivery catheter,across the delivery catheter junction, and into the other one of thefirst delivery catheter or the second delivery catheter. The firstdelivery catheter and the second delivery catheter are retracted fromthe left ventricle of the patient. In certain embodiments, the distalend of the first delivery catheter and the distal end of the seconddelivery catheter are advanced through a puncture in the left ventricle.In other embodiments, the distal end of the first delivery catheter andthe distal end of the second delivery catheter are advanced through theaorta of the patient. In some embodiments, the distal end of the firstdelivery catheter magnetically engages the distal end of the seconddelivery catheter. In some embodiments, a first steerable sheath and asecond steerable sheath are advanced into the left ventricle. In theseembodiments, the act of advancing the distal end of the first deliverycatheter into the left ventricle comprises advancing the distal end ofthe first delivery catheter through an interior of the first steerablesheath, and the act of advancing the distal end of the second deliverycatheter into the left ventricle comprises advancing the distal end ofthe second delivery catheter through an interior of the second steerablesheath. In certain embodiments, an introducer sheath is advanced intothe left ventricle through a puncture in the left ventricle. In theseembodiments, the act of advancing the first steerable sheath and thesecond steerable sheath into the left ventricle comprises advancing thefirst steerable sheath and the second steerable sheath through theintroducer sheath. In some embodiments, a locking member is attached toportions of the support band material and advanced over the portions ofthe support band material, thereby adjusting a diameter of a loop formedby the support band material and the locking member and surrounding thechordae tendineae. The act of advancing the locking member over theportions of the support band material can be performed using a pushertube. In some embodiments, the loop formed by the support band materialand the locking member can be positioned around the outflow side of themitral valve. An expandable prosthetic heart valve can be advanced intothe mitral valve and the interior of the loop formed by the support bandmaterial and the locking member while the prosthetic heart valve is in acompressed state. The expandable prosthetic heart valve can be expandedinto an uncompressed state, thereby causing one or more native leafletsof the mitral valve to be frictionally secured between the loop and theexpandable prosthetic heart valve. Portions of the support band materialthat do not form part of the loop can be severed, thereby releasing theloop.

In another disclosed embodiment, a partial loop is formed around thechordae tendineae of a patient's heart with a cord of biocompatiblematerial. A locking member is attached to portions of the cord ofbiocompatible material. The locking member is advanced toward thechordae tendineae along the portions of the cord of biocompatiblematerial, thereby decreasing a diameter of a loop formed by the cord ofbiocompatible material and the locking member. In certain embodiments,an expandable prosthetic heart valve is positioned into the interior ofthe patient's mitral valve, the loop formed by the cord of biocompatiblematerial and the locking member is positioned around an outflow side ofthe patient's mitral valve so that the native leaflets of the mitralvalve open into the interior of the loop, and the expandable prostheticheart valve is expanded, thereby causing an exterior surface of theexpandable prosthetic heart valve to urge the native leaflets of themitral valve against an interior surface of the loop and to frictionallysecure the expandable prosthetic heart valve to the native leaflets ofthe mitral valve. In some embodiments, portions of the cord ofbiocompatible material are cut in order to release the loop formed bythe cord of biocompatible material and the locking member. In certainembodiments, an expandable prosthetic heart valve is advanced into theinterior of the patient's mitral valve and expanded. The exterior of theexpandable prosthetic heart valve can comprise one or more fasteningmechanisms configured to engage the native leaflets of the mitral valveand at least temporarily secure the expandable prosthetic heart to thenative leaflets. In certain implementations of these embodiments, theloop formed by the cord of biocompatible material and the locking memberis positioned around an outflow side of the patient's mitral valve sothat the loop circumscribes the native leaflets of the mitral valve andthe expanded prosthetic heart valve. In these embodiments, the act ofadvancing the locking member can decrease the diameter of the loopformed by the cord of biocompatible material and the locking member to adiameter that causes the expanded prosthetic heart valve to befrictionally secured to the native leaflets of the mitral valve. Incertain particular embodiments, the locking member is locked at adesired position along the portions of the support band material,thereby forming a support band having a substantially fixed diameter. Insome embodiments, the locking member can be unlocked, and the locationof the locking member adjusted along the portions of the support bandmaterial. In certain embodiments, the act of forming the partial looparound the chordae tendineae of the patient's heart is performed usingone or more delivery catheters inserted through the aortic arch of thepatient. In other embodiments, the act of forming the partial looparound the chordae tendineae of the patient's heart is performed usingone or more delivery catheters inserted through a puncture in the leftventricle of the patient.

Another disclosed embodiment is a system that comprises a first deliverycatheter having a first distal end region and a first distal end, asecond delivery catheter having a second distal end region and a seconddistal end, and an introducer sheath defining an interior that isconfigured to receive the first delivery catheter and the seconddelivery catheter. In these embodiments, the first distal end region issteerable into a first semi-circular shape, the second distal end regionis steerable into a second semi-circular shape, the first distal end hasa first magnetic polarity, and the second distal end has a secondmagnetic polarity opposite the first magnetic polarity. In certainembodiments, the introducer sheath is rigid and is sized for insertionthrough a puncture in the left ventricle of a patient. In otherembodiments, the introducer sheath is bendable and is sized forinsertion into the aortic arch of a patient. In some embodiments, thesystem further comprises a first catheter delivery sheath and a secondcatheter delivery sheath. In these embodiments, the first catheterdelivery sheath defines a first interior configured to receive the firstdelivery catheter and has a first distal sheath region that naturallyassumes a first arced shape. Further, the second catheter deliverysheath defines a second interior configured to receive the seconddelivery catheter and has a second distal sheath region that naturallyassumes a second arced shape. In these embodiments, the interior of theintroducer sheath is further configured to receive the first catheterdelivery sheath, the second catheter delivery sheath, the first deliverycatheter, and the second delivery catheter. In certain embodiments, thefirst catheter delivery sheath and the second catheter delivery sheathare manufactured at least in part from a shape-memory alloy.

Another disclosed embodiment is a system comprising a pusher tubedefining a first pusher tube lumen and a second pusher tube lumen and alocking member defining a first locking member lumen and a secondlocking member lumen. In these embodiments, the first and second pushertube lumens are sized to receive respective portions of a cord ofmaterial, and the first and second locking member lumens are also sizedto receive the respective portions of the cord and are furtherconfigured to allow movement of the locking member in a first directionalong the respective portions of the cord when pushed by the pusher tubebut prevent movement of the locking member in a second directionopposite the first direction along the respective portions of the cord.In certain embodiments, the pusher tube further comprises a rotatablecutting element located at a distal end of the pusher tube, therotatable cutting element being controllable from a proximal region ofthe pusher tube. In some embodiments, the first locking member lumen andthe second locking member lumen each comprise one or more angled collarsor teeth. In certain embodiments, the system further comprises anintroducer sheath having an introducer sheath interior through which thepusher tube and the locking member are advanceable. In some embodiments,the system further comprises a prosthetic-heart-valve-delivery catheter.In these embodiments, the introducer sheath interior is furtherconfigured to simultaneously receive the pusher tube and theprosthetic-heart-valve-delivery catheter.

Another disclosed embodiment is a system comprising a locking memberconfigured to receive two portions of a cord of biocompatible materialand to secure the two portions in a desired position relative to oneanother, an adjustment tool configured to position the locking memberinto the desired position and to engage a locking mechanism in thelocking member that secures the locking member to the two portions atthe desired position, a balloon catheter on which an expandableprosthetic heart valve is disposed, and an introducer sheath defining aninterior in which the adjustment tool and the balloon catheter can besimultaneously located. In certain embodiments, the adjustment tool isfurther configured to disengage the locking mechanism in the lockingmember, thereby unlocking the locking member from the two portions ofthe cord. In particular embodiments, the locking member comprises a pinmember and a ring member. The pin member can have a first end, a secondend, and openings for receiving the two portions of the cord, and thering member can have openings for receiving the two portions of the cordand be configured to receive at least a portion of the first end of thepin member. In some embodiments, the adjustment tool comprises a forkmember positioned at a distal end of the adjustment tool, an inner pushmember, and an outer push member. In these embodiments, the inner pushmember can be contained within a lumen of the adjustment tool and theouter push member can have a greater diameter than the inner push memberand surround at least a portion of the inner push member.

Another disclosed embodiment comprises a support band having an annularbody that defines a support band interior. The support band of thisembodiment is formed from a biocompatible material having a first endthat is secured to an opposite second end via a locking mechanism. Thesupport band of this embodiment is sized such that it can be positionedadjacent to the outflow side of the mitral valve of a patient andthereby circumscribe the native leaflets of the mitral valve. Moreover,the support band interior has a fixed diameter when the first end issecured to the second end such that when an expandable prosthetic heartvalve is expanded within the mitral valve and within the support bandinterior, the native leaflets of the mitral valve become pinched betweenthe expandable prosthetic heart valve and the support band, therebyfrictionally securing the expandable prosthetic heart valve to themitral valve. In certain embodiments, the first end of the support bandhas a larger diameter than the second end, and the first end of thesupport band defines an interior into which the second end can beinserted and secured by the locking mechanism. In some embodiments, thelocking mechanism comprises a snap-fit connection formed between thefirst end and the second end of the support band. In certainembodiments, the locking mechanism comprises a locking member having afirst lumen configured to receive the first end of the support band anda second lumen configured to receive the second end of the support band,the first lumen and the second lumen each comprising one or more angledteeth or collars that allow movement of the locking mechanism along thesupport band in only a single direction. In some embodiments, thelocking mechanism comprises a multi-element mechanism that can beselectively locked to and unlocked from the first end and the second endof the support band. In certain embodiments, one or more clamps arepositioned on the support band.

In another disclosed embodiment, a prosthetic heart valve is deliveredinto an interior of a native heart valve and expanded. A support band isdelivered to a position on or adjacent to the surface of the outflowside of the native heart valve such that an interior of the support bandsurrounds at least a portion of the prosthetic heart valve and at leasta portion of one or more native leaflets of the native heart valve. Thediameter of the support band is adjusted until the one or more nativeleaflets of the native heart valve are frictionally secured between thesupport band and the prosthetic heart valve. The prosthetic heart valvecan be an expandable prosthetic heart valve and expanded once it isdelivered into the interior of the native heart valve. The support bandcan be formed from a shape-memory metal or cord of support band materialand an adjustable locking member through which portions of the cordextend. During delivery of the support band, the support band can bedisconnected from at least a delivery catheter once the one or morenative leaflets of the native heart valve are frictionally securedbetween the support band and the prosthetic heart valve (e.g., bycutting through material used to form the support band).

Other exemplary embodiments disclosed herein are integrated systems fordelivering a support stent and a prosthetic valve to a patient's aorticvalve. Exemplary embodiments of the system comprise one or more supportstent delivery catheters, one or more prosthetic valve deliverycatheters at least partially positioned in the interior of the one ormore support stent delivery catheters, an expandable support stentreleasably coupled to the one or more support stent delivery catheters,and an expandable prosthetic valve releasably coupled to the one or moreprosthetic valve delivery catheters. The system can comprise a maincatheter at least partially enclosing the one or more support stentdelivery catheters and the one or more prosthetic valve deliverycatheters. In certain implementations, the one or more support stentdelivery catheters can comprise a stent delivery outer catheter (whichcan have a distal end with an outer fork portion that comprises aplurality of flexible outer prongs) and a stent delivery inner catheterat least partially positioned in the interior of the stent deliveryouter catheter (the stent delivery inner catheter can have a distal endwith an inner fork portion that comprises a plurality of flexible innerprongs). Furthermore, the expandable support stent can comprise aplurality of retaining arms that are releasably connected tocorresponding ones of the outer prongs of the outer fork portion andcorresponding ones of the inner prongs of the inner fork portion. Infurther implementations, the one or more prosthetic valve deliverycatheters comprise a prosthetic valve delivery outer catheter (which canhave a distal end with an outer fork portion that comprises a pluralityof flexible outer prongs) and a prosthetic valve delivery inner catheterat least partially positioned in the interior of the prosthetic valvedelivery outer catheter (the prosthetic valve delivery inner cathetercan have a distal end with an inner fork portion that comprises aplurality of flexible inner prongs). Furthermore, the expandableprosthetic valve can comprise a plurality of retaining arms that arereleasably connected to corresponding ones of the outer prongs of theouter fork portion and corresponding ones of the inner prongs of theinner fork portion. In some implementations, the one or more supportstent delivery catheters comprise a stent delivery outer catheter (whichcan have a distal end with an outer fork portion that comprises aplurality of flexible outer prongs) and a plurality of wires at leastpartially positioned in the interior of the stent delivery outercatheter. Furthermore, the expandable support stent can comprise aplurality of retaining arms releasably connected to corresponding onesof the outer prongs of the outer fork portion and corresponding ones ofthe distal ends of the wires. In certain implementations, the one ormore prosthetic valve delivery catheters comprise a prosthetic valvedelivery outer catheter (which can have a distal end with an outer forkportion that comprises a plurality of flexible outer prongs) and aplurality of wires at least partially positioned in the interior of theprosthetic valve delivery outer catheter. Furthermore, the expandableprosthetic valve can comprise a plurality of retaining arms releasablyconnected to corresponding ones of the outer prongs of the outer forkportion and corresponding ones of the distal ends of the wires. Infurther implementations, the system further comprises a prosthetic valvesheath positioned in the interior of the one or more support stentdelivery catheters but on an exterior of the one or more prostheticvalve delivery catheters. In these implementations, the expandablesupport stent can be a self-expanding support stent, and theself-expanding support stent can be positioned within and held in acompressed state by the prosthetic valve sheath. In someimplementations, the one or more prosthetic valve delivery catheterscomprises a prosthetic valve delivery catheter having a distal balloonportion on which the expandable prosthetic valve is disposed. In certainimplementations, the expandable prosthetic valve is located distally ofthe expandable support stent, whereas in other implementations theexpandable prosthetic valve is located concentrically within theexpandable support stent. In further implementations, the systemadditionally comprises a nose cone (e.g., a collapsible nose cone)connected to a distal end of one of the one or more valve deliverycatheters. In certain implementations, the system further comprises anose cone catheter positioned in the interior of the one or more valvedelivery catheters, and a nose cone (e.g., a collapsible nose cone)coupled to a distal end of the nose cone catheter. In furtherimplementations, the expandable support stent is generally annular andcomprises shaped portions configured to frictionally secure nativeleaflets of a patient's heart valve against an exterior surface of aprosthetic valve when the patient's heart valve has been replaced by theprosthetic valve.

Embodiments of another disclosed system comprise one or more prostheticvalve delivery catheters, one or more support stent delivery cathetersat least partially positioned in the interior of the one or moreprosthetic valve delivery catheters, an expandable prosthetic valvereleasably coupled to the one or more prosthetic valve deliverycatheters, and an expandable support stent releasably coupled to the oneor more support stent delivery catheters. The system can furthercomprise a main catheter at least partially enclosing the one or moresupport stent delivery catheters and the one or more prosthetic valvedelivery catheters. In certain implementations, the one or more supportstent delivery catheters comprise a stent delivery inner fork catheter(which can have a distal end with an inner fork portion that comprises aplurality of flexible inner prongs) and a stent delivery outer forkcatheter positioned in the interior of the stent delivery inner forkcatheter (the stent delivery outer fork catheter can have a distal endwith an outer fork portion that comprises a plurality of flexible outerprongs). The expandable support stent can comprise a plurality ofretaining arms releasably connected to corresponding ones of the outerprongs of the outer fork portion and corresponding ones of the innerprongs of the inner fork portion. In further implementations, the systemfurther comprises a nose cone catheter, and an elongated nose coneconnected to a distal end of the nose cone catheter. In suchimplementations, the stent delivery inner fork catheter, the stentdelivery outer fork catheter, and the expandable support stent can beselectively enclosable within the elongated nose cone. In someimplementations, the system further comprises a nose cone catheter, anda nose cone (e.g., a collapsible nose cone) connected to a distal end ofthe nose cone catheter. In certain implementations, the one or moreprosthetic valve delivery catheters comprise a prosthetic valve deliveryouter catheter (which can have a distal end with an outer fork portionthat comprises a plurality of flexible outer prongs) and a prostheticvalve delivery inner catheter at least partially positioned in theinterior of the prosthetic valve delivery outer catheter (the prostheticvalve delivery inner catheter can have a distal end with an inner forkportion that comprises a plurality of flexible inner prongs). Theexpandable prosthetic valve can comprise a plurality of retaining armsreleasably connected to corresponding ones of the outer prongs of theouter fork portion and corresponding ones of the inner prongs of theinner fork portion. In further implementations, the system additionallycomprises a prosthetic valve sheath positioned in the interior of theexpandable support stent but on an exterior of the one or moreprosthetic valve delivery catheters and the one or more support stentdelivery catheters. In such implementations, the expandable prostheticvalve can be a self-expanding prosthetic valve positioned within andheld in a compressed state by the prosthetic valve sheath. In someimplementations, the one or more prosthetic valve delivery catheterscomprise a prosthetic valve delivery catheter having a distal balloonportion on which the expandable prosthetic valve is disposed. In certainimplementations, the expandable prosthetic valve is located proximallyof the expandable support stent, whereas in other implementations theexpandable prosthetic valve is located concentrically within theexpandable support stent. In further implementations, the expandablesupport stent is generally annular and comprises shaped portionsconfigured to frictionally secure native leaflets of a patient's heartvalve against an exterior surface of a prosthetic valve when thepatient's heart valve has been replaced by the prosthetic valve.

Embodiments of another disclosed system comprise a main catheter, one ormore support stent delivery catheters positioned in the interior of themain catheter, an expandable support stent positioned in the interior ofthe main catheter in a radially compressed state (the expandable supportstent can comprise a plurality of retaining arms releasably connected tothe one or more support stent delivery catheters), a nose cone catheterpositioned in the interior of the one or more support stent deliverycatheters, and a collapsible nose cone coupled to a distal end of thenose cone catheter. The nose cone catheter and the collapsible nose conecan be retracted into the interior of one of the one or more supportstent delivery catheters. In certain implementations, the collapsiblenose cone comprises a wire mesh structure (e.g., formed from ashape-memory alloy). In other implementations, the collapsible nose coneis formed of a collapsible foam.

Embodiments of another disclosed system comprise a main catheter, one ormore delivery catheters positioned in the interior of the main catheterand configured to deliver an implantable device, a nose cone catheterpositioned in the interior of the one or more support stent deliverycatheters, and a collapsible nose cone coupled to a distal end of thenose cone catheter. The nose cone catheter and the collapsible nose conecan be retracted into the interior of one of the one or more supportstent delivery catheters. The collapsible nose cone can comprise a wiremesh structure (e.g., wherein the wires of the wire mesh structure areformed from a shape-memory alloy) or be formed from a collapsible foam.

Exemplary methods for delivering a support structure together with theexpandable prosthetic valve using a single dual-stage system are alsodisclosed. In certain embodiments, a support structure and an expandableprosthetic valve are advanced through the aortic arch of a patient usinga delivery system, the support structure is delivered to a position onor adjacent to the surface of the outflow side of the aortic valve (thesupport structure defining a support-structure interior), the expandableprosthetic valve is delivered into the aortic valve and into thesupport-structure interior, and the expandable prosthetic heart valve isexpanded while the expandable prosthetic heart valve is in thesupport-structure interior and while the support structure is at theposition on or adjacent to the surface of the outflow side of the aorticvalve, thereby causing one or more native leaflets of the aortic valveto be frictionally secured between the support structure and theexpanded prosthetic heart valve. In certain implementations, the act ofdelivering the support structure comprises advancing a stent deliveryouter catheter and a stent delivery inner catheter through a distal endof a guide catheter of the delivery system, thereby causing the supportstructure to expand into an expanded state. In such implementations, theact of delivering the support structure can further comprise, while thesupport structure is in the expanded state, guiding the supportstructure to the position on or adjacent to the surface of the outflowside of the aortic valve and into a desired orientation (e.g., anorientation that aligns peaks of the support structure with either thetips or the commissures of the one or more native leaflets). In furtherimplementations, the act of delivering the support structure furthercomprises retracting the stent delivery inner catheter relative to thestent delivery outer catheter, thereby causing the support structure tobe released from the stent delivery inner catheter and the stentdelivery outer catheter. In some implementations, the act of deliveringthe expandable prosthetic valve comprises advancing a balloon portion ofa balloon catheter into the aortic valve of the patient, the expandableprosthetic valve being disposed around the balloon portion of theballoon catheter. The expandable prosthetic valve can then be expandedby inflating the balloon portion of the balloon catheter. In certainimplementations, the act of delivering the expandable prosthetic valvecomprises advancing at least a portion of a prosthetic valve sheath intothe aortic valve while the prosthetic valve sheath encloses one or moreprosthetic valve delivery catheters. In such implementations, the act ofexpanding the expandable prosthetic valve can further compriseretracting the prosthetic valve sheath relative to the one or moreprosthetic valve delivery catheters and the expandable prosthetic valve,thereby causing the expandable prosthetic valve to be advanced through adistal end of the prosthetic valve sheath and to expand within theaortic valve. A prosthetic valve delivery inner catheter can then beretracted relative to a prosthetic valve delivery outer catheter,thereby causing the prosthetic valve to be released from the prostheticvalve delivery inner catheter and the prosthetic valve delivery outercatheter. In some implementations, the act of delivering the expandableprosthetic heart valve comprises advancing or retracting one or moreprosthetic valve delivery catheters relative to a surrounding one ormore support stent delivery catheters. In further implementations, anose cone catheter can be retracted, thereby causing a collapsible nosecone of the delivery system to be withdrawn into a catheter of thedelivery system in a collapsed state.

In embodiments of another disclosed method, a support structure and anexpandable prosthetic valve are advanced through a puncture in the leftventricle of a patient and toward the aortic valve of the patient usinga delivery system, the support structure is delivered to a position onor adjacent to the surface of the outflow side of the aortic valve (thesupport structure defining a support-structure interior), the expandableprosthetic valve is delivered into the aortic valve and into thesupport-structure interior, and the expandable prosthetic heart valve isexpanded while the expandable prosthetic heart valve is in thesupport-structure interior and while the support structure is at theposition on or adjacent to the surface of the outflow side of the aorticvalve, thereby causing one or more native leaflets of the aortic valveto be frictionally secured between the support structure and theexpanded prosthetic heart valve. In certain implementations, the act ofdelivering the support structure comprises advancing one or more stentdelivery catheters through a proximal end of an elongated nose cone ofthe delivery system, thereby causing the support structure to expandinto an expanded state. In such implementations, the act of deliveringthe support structure can further comprise, while the support structureis in the expanded state, guiding the support structure to the positionon or adjacent to the surface of the outflow side of the aortic valveand into a desired orientation (e.g., an orientation that aligns peaksof the support structure with either the tips or the commissures of theone or more native leaflets). The act of delivering the supportstructure can comprise advancing a stent delivery inner catheterdistally relative to a stent delivery outer catheter, thereby causingthe support structure to be released from the stent delivery innercatheter and the stent delivery outer catheter. The elongated nose conecan then be withdrawn through the expanded support structure. In certainimplementations, the act of delivering the expandable prosthetic valvecomprises advancing a balloon portion of a balloon catheter into theaortic valve of the patient, the expandable prosthetic valve beingdisposed around the balloon portion of the balloon catheter. In theseimplementations, the expandable prosthetic valve can be expanded byinflating the balloon portion of the balloon catheter. In furtherimplementations, the act of delivering the expandable prosthetic valvecomprises advancing at least a portion of a prosthetic valve sheath intothe aortic valve while the prosthetic valve sheath encloses one or moreprosthetic valve delivery catheters and the expandable prosthetic valve.In these implementations, the act of expanding the expandable prostheticvalve can further comprise retracting the prosthetic valve sheathrelative to the one or more prosthetic valve delivery catheters and theexpandable prosthetic valve, thereby causing the expandable prostheticvalve to be uncovered by the prosthetic valve sheath and to expandwithin the aortic valve. A prosthetic valve delivery inner catheter canthen be retracted relative to a prosthetic valve delivery outercatheter, thereby causing the expandable prosthetic valve to be releasedfrom the prosthetic valve delivery inner catheter and the prostheticvalve delivery outer catheter. In some implementations, the act ofdelivering the expandable prosthetic heart valve comprises advancing orretracting one or more support stent delivery catheters relative to asurrounding one or more prosthetic valve delivery catheters. In furtherimplementations, the support structure and the expanded prosthetic heartvalve are disconnected from the delivery system once the one or morenative leaflets of the native heart valve are frictionally securedbetween the support structure and the expanded prosthetic heart valve.

Exemplary embodiments of the support stent or support structure that canbe used in the disclosed systems are also described. For example,certain embodiments comprise a support stent having an annular body thatdefines one or more peaks and one or more valleys along itscircumference, where a peak or valley of the support stent comprises oneor more outer strut members and one or more inner strut members, the oneor more outer strut members being separated from the one or more innerstrut members by an aperture and being outwardly angled from the one ormore inner strut members. In certain implementations, each of the peaksor the valleys of the support stent comprise one or more of the outerstrut members angled outwardly from one or more of the inner strutmembers. The support stent can consist of six peaks and six valleys. Thesupport stent can be made of a shape-memory alloy. The annular body canbe sinusoidal or saw-tooth shaped along its circumference. Thebiocompatible material can extend across the aperture between the one ormore outer strut members and the one or more inner strut members. Atleast one of the one or more outer strut members can comprise aprojection defining an interior space, the interior space beingconfluent with the aperture. The one or more outer strut memberscomprise a first outer strut member and a second outer strut member, thefirst outer strut member and the second outer strut member beingconfigured to cross one another when the support stent is in theuncompressed state. A first distal end of the first outer strut memberand a second distal end of the second outer strut member can beconnected by a connecting member. One or more of the peaks of thesupport stent can include enlarged circular head members or enlargedclover-shaped head members.

Other embodiments comprise a support stent having an annular body thatdefines one or more peaks and one or more valleys along itscircumference, and one or more covers that at least partially cover theannular body of the support stent, the one or more covers comprising abiocompatible material. Each of the one or more valleys of the supportstent can be at least partially covered by respective ones of the one ormore covers. The one or more covers can comprise a plurality of tubularcovers that at least partially cover the annular body of the supportstent. The one or more covers can comprise one or more covers thatextend across one or more of the valleys defined by the support stent.The biocompatible material can be a biocompatible silicone, cloth, orfoam. At least one of the one or more covers can be formed from at leasta first material and a second material, the first material being thickerthan the second material. The thicker first material can be positionedon an inward-facing side of the support stent, or the thicker firstmaterial can be positioned at or adjacent to respective nadirs of theone or more valleys of the support stent. Certain implementationsfurther comprise a mechanism configured to allow one or more of thecovers to hang below the support stent when the support stent is in thecompressed state and to move the one or more of the covers into a finalposition on the support stent when the support stent is expanded intothe uncompressed state. One or more of the peaks of the support stentcan include enlarged circular head members or enlarged clover-shapedhead members.

Other embodiments comprise a support stent having an annular body thatdefines one or more peaks and one or more valleys along itscircumference, and one or more projections extending outwardly from thesupport stent at locations at or adjacent to respective nadirs of one ormore of the valleys. The one or more projections can be U-shapedprojections that curve upwards relative the one or more of the valleys.The one or more projections can alternatively be loop-shapedprojections. Each of the loop-shaped projections can include a first endconnected to a first one of the valleys and a second end connected to asecond one of the valleys adjacent to the first one of the valleys.Certain implementations further comprise a coating of biocompatiablematerial that at least partially coats the annular body of the supportstent or one or more covers that at least partially cover the annularbody of the support stent.

Also disclosed herein are leaflet stabilizing systems that can be usedwhen delivering embodiments of the disclosed support structures (supportstents) to a native heart valve. Certain exemplary embodiments of suchsystem comprise a main catheter, a leaflet stabilizer outer catheterpositioned in the interior of the main catheter, a leaflet stabilizerinner catheter positioned in the interior of the leaflet stabilizerouter catheter, and one or more retractable leaflet stabilizer arms thatare configured to extend radially outward from the leaflet stabilizerouter catheter and retract radially inward toward the leaflet stabilizerouter catheter based on relative motion between the leaflet stabilizerouter catheter and the leaflet stabilizer inner catheter. The one ormore retractable leaflet stabilizer arms can include distal ends thatform one of an open loop, a closed loop, a hook, a clover-shapedprofile, or a leaf-shaped profile. The one or more retractable leafletstabilizer arms can comprise three retractable leaflet stabilizer arms,each of the three retractable leaflet stabilizer arms being configuredto engage respective native valve leaflets of an aortic valve. Thesystem can further comprise a respective pivot arm for each of the oneor more retractable leaflet stabilizer arms. Each of the pivot arms canhave a first end pivotally coupled to a distal portion of the leafletstabilizer outer catheter and a second end pivotally coupled to aportion of a respective retractable leaflet stabilizer arm. In certainimplementations, the system comprises a nose cone coupled to a distalend of the leaflet stabilizer inner catheter. The nose cone can be atleast partially hollow. Further, in particular embodiments, the one ormore retractable leaflet stabilizer arms are configured to beretractable into the at least partially hollow nose cone in anun-deployed state and are further configured to be uncovered from the atleast partially hollow nose cone in a deployed state. The one or moreretractable leaflet stabilizer arms can be formed from a variety ofmaterials, including a shape memory alloy. In certain implementations,each of the one or more retractable leaflet stabilizer arms includes agenerally flat upper surface and an inwardly-angled lip portion.

Other exemplary embodiments of a leaflet retaining system comprises amain catheter, the main catheter comprising one or more stabilizer armlumens and further comprising a distal end and a proximal end. In theseembodiments, the systems further comprise one or more leaflet stabilizerarms, each of the one or more leaflet stabilizer arms being positionedin the interior of a respective one of the one or more stabilizer armlumens, and each of the one or more leaflet stabilizer arms furtherhaving a respective leaflet stabilizer arm lumen. The one or moreleaflet stabilizer arms can be configured to be retractable into the oneor more stabilizer arm lumens in an undeployed state and to beextendable through the distal end of the main catheter in a deployedstate. Some embodiments of the system further comprise one or moreballoon portions, each of the one or more balloon portions being coupledto a distal end of a respective one of the one or more more leafletstabilizer arms. The one or more balloon portions can be sized to engagenative heart valve leaflets when expanded. The system can furthercomprise at least one inflation lumen fluidly coupled to the leafletstabilizer arm lumens of the one or more leaflet stabilizer arms. Inother embodiments, each of the one or more leaflet stabilizer armscomprises an inflation port. The one or more leaflet stabilizer arms canbe formed from a variety of materials, including a shape-memory alloy.In certain implementations, the one or more leaflet stabilizer arms areconfigured to extend radially outwardly from the distal end of the maincatheter and backward toward the proximal end of the main catheter whendeployed from the main catheter. In some implementations, the systemfurther comprises a handle at or adjacent to the proximal end of themain catheter, the handle being coupled to each of the one or moreleaflet stabilizer arms such that the one or more leaflet stabilizerarms can be moved in unison with movement of the handle.

Also disclosed are exemplary methods for stabilizing leaflets (e.g.,during delivery of a support structure or support stent to a nativeheart valve). In certain embodiments, for example, a leaflet stabilizingsystem including one or more leaflet stabilizing arms is advancedthrough a puncture in the left ventricle of a patient and through theaortic valve of the patient. The one or more leaflet stabilizing armsare caused to engage respective native heart valve leaflets of theaortic valve and urge the respective native heart valve leafletsradially inward toward a center of the leaflet stabilizing system. Insome embodiments, a support structure is advanced through the aorticarch of the patient and toward the aortic valve using a supportstructure delivery system, and the support structure is delivered to aposition on or adjacent to the surface of the outflow side of the aorticvalve. The act of delivering the support structure can include advancingthe support structure toward the one or more leaflet stabilizing arms sothat the leaflet stabilizing arms contact the support structure. Thecontact between the support structure and the leaflet stabilizing armscan cause the support structure to rotate to a desired orientationrelative to the aortic valve. In certain embodiments, the leafletstabilizing system is removed from the aortic valve, thereby releasingthe respective native heart valve leaflets such that at least a portionof the respective native heart valve leaflets are located in an interiorof the support structure when the respective native heart valve leafletsare open. An expandable prosthetic valve can then be delivered into theaortic valve and into the support-structure interior. The expandableprosthetic heart valve can be expanded while the expandable prostheticheart valve is in the support-structure interior and while the supportstructure is at the position on or adjacent to the surface of theoutflow side of the aortic valve, thereby causing the one or more nativeheart valve leaflets to be frictionally secured between the supportstructure and the expanded prosthetic heart valve. In some embodiments,the one or more leaflet stabilizing arms are extended radially outwardby moving a leaflet stabilizer outer catheter relative to a leafletstabilizer inner catheter, distal ends of the extended leafletstabilizing arms are positioned against the surfaces of the respectivenative heart valve leaflets on the outflow side of the aortic valve, andthe one or more leaflet stabilizing arms are retracted radially inwardby moving the leaflet stabilizer outer catheter relative to the leafletstabilizer inner catheter, thereby causing the leaflet stabilizing armsto urge the respective native heart valve leaflets radially inwardtoward the center of the leaflet stabilizing system. In otherembodiments, the one or more leaflet stabilizing arms are extendedradially outward by advancing an at least partially hollow nose conedistally relative to the one or more leaflet stabilizing arms, therebyrevealing at least a portion of the leaflet stabilizing arms from aninterior of the at least partially hollow nose cone, and distal ends ofthe extended leaflet stabilizing arms are positioned against the outflowside surfaces of the respective native heart valve leaflets. In stillother embodiments, the one or more leaflet stabilizing arms are advancedthrough lumens of the leaflet stabilizing system so that distal ends ofthe leaflet stabilizing arms extend outwardly from a distal end of theleaflet stabilizing system and are positioned near or adjacent tosurfaces of the respective native heart valve leaflets on the outflowside of the aortic valve. In such embodiments, one or more balloonslocated at the distal ends of the leaflet stabilizing arms can beinflated so that the inflated balloons contact and urge the respectivenative heart valve leaflets radially inward toward the center of theleaflet stabilizing system

Other disclosed embodiments include embodiments of support stents orsupport structures that include one or more additional mechanisms forsecuring the support stent to a prosthetic heart valve. For example,certain embodiments disclosed herein comprise a support stent having anannular body that defines one or more peaks and one or more valleysalong its circumference, the support stent being radially compressibleinto a compressed state and self expandable into an uncompressed state,the support stent being sized such that it can be positioned within theaorta of a patient at a location adjacent to the aortic valve andthereby circumscribe the aortic valve, the support stent furthercomprising one or more projections extending inwardly toward an interiorof the support stent from locations at or adjacent to respective apicesof one or more of the peaks. In some embodiments, the one or moreprojections are projections that project upwardly relative to thehorizontal plane of the support stent. In certain embodiments, the oneor more projections are configured to engage a frame of a prostheticheart valve when the one or more projections extend through one or moreopposing apertures in the frame. In some embodiments, each of the one ormore projections is bendable. In certain embodiments, at least onerespective peak of the support stent includes a retaining arm, and theat least one respective peak further includes a respective one of theprojections positioned at a bottom edge of the at least one respectivepeak. In such embodiments, the at least one respective peak of thesupport stent can further include a first set of one or more sutures ona first side of the at least one respective peak and a second set of oneor more sutures on a second side of the at least one respective peak.Further, a wire can extend through an aperture of the retaining arm ofthe at least one respective peak, through the first set of one or moresutures, and through the second set of one or more sutures, the wirefurther engaging the respective one of the projections and restrainingthe respective one of the projections so that the respective one of theprojections does not protrude inward.

Other exemplary embodiments disclosed herein comprise a support stenthaving an annular body that defines one or more peaks and one or morevalleys along its circumference, the support stent being radiallycompressible into a compressed state and self expandable into anuncompressed state, the support stent being sized such that it can bepositioned within the aorta of a patient at a location adjacent to theaortic valve and thereby circumscribe the aortic valve, the body of thesupport stent having a diameter or width along at least a portion of thebottom half of the support stent that is greater than a diameter orwidth along at least a portion of the upper half of the support stent.In some embodiments, the top half of the support stent is more flexiblethan the bottom half. In certain embodiments, the support stent isformed from a shape-memory alloy. In some embodiments, the support stenthas a generally frustoconical shape in an expanded state.

Further exemplary embodiments disclosed herein comprise a support stenthaving an annular body that defines one or more peaks and one or morevalleys along its circumference, the support stent being radiallycompressible into a compressed state and self expandable into anuncompressed state, the support stent being sized such that it can bepositioned within the aorta of a patient at a location adjacent to theaortic valve and thereby circumscribe the aortic valve, the supportstent further comprising one or more extension portions extendinglongitudinally downward from a bottom edge of the support stent. In someembodiments, the support stent further comprises one or moreinward-facing projections located at a distal end of one or more of theextension portions. The inward-facing projections can be hook-shapedprojections, platform-shaped projections, or spoon-shaped projections.Additionally, the inward-facing projections can be configured to engagea bottom edge of a frame of a prosthetic heart valve. Certainembodiments further comprise a ring-shaped member coupled to distal endsof the one or more extension portions. In some embodiments, the one ormore extension portions extend from the bottom edges of respectivevalleys of the support stent. In particular embodiments, the one or moreextension portions are formed from respective valleys of the supportstent. In some embodiments, the one or more extension portions comprisethree extension portions, each of the extension portions beingconfigured to extend through the aortic valve at respective commissuresbetween native valve leaflets of the aortic valve. Any of the extensionportions in the disclosed embodiments can be bendable.

Other exemplary embodiments disclosed herein comprise a support stenthaving an annular body that defines one or more peaks and one or morevalleys along its circumference, the support stent being radiallycompressible into a compressed state and self expandable into anuncompressed state, the support stent being sized such that it can bepositioned within the aorta of a patient at a location adjacent to theaortic valve and thereby circumscribe the aortic valve, the body of thesupport stent having an hourglass profile such that the diameter of theinterior of the support stent at a middle portion of the support stentis less than the diameter of the interior of the support stent at anupper portion and at a lower portion of the support stent.

Further exemplary embodiments disclosed herein comprise a support stenthaving an annular body that defines one or more peaks and one or morevalleys along its circumference, the support stent being radiallycompressible into a compressed state and self expandable into anuncompressed state, the support stent being sized such that it can bepositioned within the aorta of a patient at a location adjacent to theaortic valve and thereby circumscribe the aortic valve, the body of thesupport stent having an outwardly bowed portion located between an upperportion of the support stent and a lower portion of the support stent,the diameter of the interior of the support stent at the outwardly bowedportion of the support stent being greater than the diameter of theinterior of the support stent at the upper portion and at the lowerportion of the support stent.

Other exemplary embodiments disclosed herein comprise a support stenthaving an annular body that defines one or more peaks and one or morevalleys along its circumference, the support stent being radiallycompressible into a compressed state and self expandable into anuncompressed state, the support stent being sized such that it can bepositioned within the aorta of a patient at a location adjacent to theaortic valve and thereby circumscribe the aortic valve, the supportstent further comprising one or more protrusions integrally formed fromrespective valleys of the annular body, the protrusions being formed toextend inwardly toward an interior of the support stent. The one or moreprotrusions can further include respective apertures. In suchembodiments, one or more wires can extend through the respectiveapertures of the protrusions. Any of the one or more protrusions can bebendable.

Further exemplary embodiments disclosed herein comprise a support stenthaving an annular body that defines one or more peaks and one or morevalleys along its circumference, the support stent being radiallycompressible into a compressed state and self expandable into anuncompressed state, the support stent being sized such that it can bepositioned within the aorta of a patient at a location adjacent to theaortic valve and thereby circumscribe the aortic valve, the supportstent further comprising one or more protrusions configured to extendinwardly toward an interior of the support stent in a natural state, theone or more protrusions originating at locations adjacent to the bottomedges of respective valleys of the support stent or at locations alongthe body of the support stent between the one or more peaks and valleysof the support stent. The one or more protrusions can further includerespective apertures. In such embodiments, one or more wires can extendthrough the respective apertures of the protrusions. In certainembodiments, the one or more protrusions are configured to engage aframe of a prosthetic heart valve when the one or more protrusionsextend through one or more opposing apertures in the frame. Further, theone or more protrusions can be bendable. In particular embodiments, theone or more protrusions are shaped such that the protrusions are angledupward toward a top edge of the support stent.

Other exemplary embodiments disclosed herein comprise a support stenthaving an annular body that defines one or more peaks and one or morevalleys along its circumference, the support stent being radiallycompressible into a compressed state and self expandable into anuncompressed state, the support stent being sized such that it can bepositioned within the aorta of a patient at a location adjacent to theaortic valve and thereby circumscribe the aortic valve, the supportstent further comprising one or more spherical members attached to orformed integrally with the annular body of the support stent, thespherical members being positioned at locations adjacent to the bottomedges of respective valleys of the support stent.

Also disclosed herein are embodiments of prosthetic heart valves thatcomprise mechanisms for self securing themselves to an interior of anative heart valve. In certain exemplary embodiments, for instance, aprosthetic heart valve comprises a radially expandable and compressiblesupport frame comprising a plurality of strut members interconnected toeach other to form a mesh structure, plural prosthetic leaflets securedto the inside of the support frame, and one or more native valve leafletretaining arms attached to or formed integrally with the support frame,each of the one or more native valve leaflet retaining arms having adeployed state in which at least a portion of the respective nativevalve leaflet retaining arm presses against an exterior surface of thesupport frame. In certain embodiments, one or more of the native valveleaflet retaining arms originate at or adjacent to an outflow end of thesupport frame, extend radially outward from the support frame, and loopback toward an inflow end of the support frame. In some embodiments,each of the one or more native valve leaflet retaining arms includes arespective aperture. In such embodiments, one or more wires can extendthrough the respective apertures of the one or more native valve leafletretaining arms. In some embodiments, one or more of the native leafletretaining arms includes a distal end portion that defines a largersurface area than a remainder of the respective one or more of thenative leaflet retaining arms. In certain embodiments, one or more ofthe native leaflet retaining arms originate at a location between anoutflow end of the support frame and an inflow send of the supportframe, and wherein the one or more native leaflet retaining arms extendlaterally across the exterior surface of the support frame. In someembodiments, the support frame has an intermediate portion locatedbetween an outflow end and an inflow end of the support frame, theintermediate portion of the support stent defining a diameter of theprosthetic heart valve greater than the diameter of the prosthetic heartvalve at the outflow end and the inflow end of the support frame.

Also disclosed herein are exemplary methods for mechanically securing asupport structure (support stent) to a prosthetic heart valve. Incertain exemplary methods disclosed herein a support structure isdelivered to a position on or adjacent to the surface of the outflowside of the aortic valve, the support structure defining asupport-structure interior, the support structure further comprising oneor more protrusions that are configured to extend into thesupport-structure interior when the protrusions are in a natural state;an expandable prosthetic valve is delivered into the aortic valve andinto the support-structure interior; and the expandable prosthetic heartvalve is expanded while the expandable prosthetic heart valve is in thesupport-structure interior and while the support structure is at theposition on or adjacent to the surface of the outflow side of the aorticvalve, thereby causing one or more native leaflets of the aortic valveto be frictionally secured between the support structure and theexpanded prosthetic heart valve. In certain embodiments, the expansionof the prosthetic heart valve causes one or more of the protrusions ofthe support structure to mechanically engage a frame of the expandableprosthetic valve, the mechanical engagement creating resistance tomovement of the expanded heart valve toward an inflow side of the aorticvalve relative to the support structure. In some embodiments, the one ormore protrusions are held in an undeployed position during delivery ofthe support structure to the position on or adjacent to the surface ofthe outflow side of the aortic valve, and the method further comprisesreleasing the one or more protrusions after the prosthetic heart valvehas been expanded into the support-structure interior, thereby allowingthe protrusions to move toward the natural state and thereby causing theprotrusions to mechanically engage a frame of the expandable prostheticvalve, the mechanical engagement creating resistance to movement of theexpanded heart valve toward an inflow side of the aortic valve relativeto the support structure. In certain implementations, the releasing isperformed by retracting one or more releases wires threaded throughrespective apertures of the protrusions.

Other exemplary methods disclosed herein comprise delivering a main bodyof a support structure to a position on or adjacent to the surface ofthe outflow side of the aortic valve, wherein the support structuredefines a support-structure interior and comprises one or more extensionportions that extend longitudinally downward from a bottom edge of thesupport structure, the one or more extension portions comprising distalends having one or more inward-facing projections. The act of deliveringcan comprise orienting the support structure during delivery so that theextension portions are generally aligned with commissures of the aorticvalve, and advancing the extension portions to an inflow side of theaortic valve through commissures. Such embodiments can further comprisedelivering an expandable prosthetic valve into the aortic valve and intothe support-structure interior, and expanding the expandable prostheticheart valve while the expandable prosthetic heart valve is in thesupport-structure interior and while the main body of the supportstructure is at the position on or adjacent to the surface of theoutflow side of the aortic valve, thereby causing one or more nativeleaflets of the aortic valve to be frictionally secured between thesupport structure and the expanded prosthetic heart valve and causing abottom edge of the expandable prosthetic heart valve to be adjacent toor engaged with one or more of the inward-facing projections at thedistal ends of the extension portions.

Also disclosed herein are methods of delivering a support structure anda prosthetic valve at least partially simultaneously using two separatedelivery systems. In certain exemplary methods, for example, a supportstructure is delivered to a position on or adjacent to the surface ofthe outflow side of the aortic valve using a first delivery system thatis advanced through the ascending aorta toward the outflow side of theaortic valve of a patient, and an expandable prosthetic valve isdelivered into the aortic valve and into the support-structure interiorusing a second delivery system separate from the first delivery system,the second delivery system also being advanced through the ascendingaorta toward the outflow side of the aortic valve of the patient. Theexpandable prosthetic heart valve can be expanded while the expandableprosthetic heart valve is in the support-structure interior and whilethe support structure is at the position on or adjacent to the surfaceof the outflow side of the aortic valve and while both the firstdelivery system and the second delivery system are at least partiallypositioned in the ascending aorta, the expanding of the expandableprosthetic heart valve causing one or more native leaflets of the aorticvalve to be frictionally secured between the support structure and theexpanded prosthetic heart valve. In particular embodiments, the act ofdelivering the support stent comprises advancing the first deliverysystem through a carotid artery or subclavian artery, and wherein thedelivering the expandable prosthetic heart valve comprises advancing thesecond delivery system through a femoral artery. In other embodiments,the act of delivering the expandable prosthetic heart valve comprisesadvancing the second delivery system through a carotid artery orsubclavian artery, and wherein the delivering the support structurecomprises advancing the first delivery system through a femoral artery.In still other embodiments, the method further comprises (a) advancingthe first delivery system through a left femoral artery and advancingthe second delivery system through a right femoral artery, or (b)advancing the first delivery system through the right femoral artery andadvancing the second delivery system through the left femoral artery

The foregoing and other objects, features, and advantages of thedisclosed technology will become more apparent from the followingdetailed description, which proceeds with reference to the accompanyingfigures.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an exemplary embodiment of a supportstructure according to the disclosed technology.

FIG. 2 is a cross-sectional view of a native aortic valve with thesupport structure of FIG. 1 positioned therein.

FIGS. 3 and 4 are perspective views of an exemplary delivery system forthe support structure of FIG. 1. In particular, FIG. 3 shows thedelivery system before the support structure is deployed, and FIG. 4shows the delivery system after the support structure is deployed.

FIG. 5 is an exploded view of the components of the exemplary deliverysystem shown in FIGS. 3 and 4.

FIG. 6 is a zoomed-in perspective view showing the mechanism forreleasably connecting the support structure to the exemplary deliverysystem of FIGS. 3 and 4.

FIGS. 7 and 8 are cross-sectional views of a patient's heartillustrating how the delivery system of FIGS. 3 and 4 can operate todeploy the support structure of FIG. 1 to a desired position on thepatient's aortic valve.

FIGS. 9-13 are cross-sectional views of a patient's heart illustratinghow an exemplary transcatheter heart valve (“THV”) can be deployed tothe patient's aortic valve and frictionally secured to the nativeleaflets using the support structure of FIG. 1.

FIG. 14 is a perspective view of another exemplary embodiment of asupport structure according to the disclosed technology.

FIG. 15 is a top view of the support structure embodiment shown in FIG.14

FIG. 16 is a side view of the support structure embodiment shown in FIG.14.

FIG. 17 is a cross-sectional view of a patient's heart illustrating howa delivery system can operate to deploy the support structure of FIG. 14to a desired position on the patient's aortic valve.

FIG. 18 is a cross-sectional view of a patient's heart illustrating howan exemplary THV can be deployed through the aortic arch and into thepatient's aortic valve, where it can be frictionally secured to thenative leaflets using the support structure of FIG. 14.

FIGS. 19-27 are cross-sectional view of a patient's heart illustratinghow an exemplary support band can be deployed around the native leafletsof a patient's mitral valve and used to secure a THV to the nativeleaflets of the mitral valve. In FIGS. 19-27, the support band isdeployed using a transapical approach.

FIG. 28 is a cross-sectional view of a patient's heart illustrating howan exemplary support band as in FIGS. 19-27 can be deployed through theaortic arch.

FIG. 29 is a top view of an exemplary locking member that can be used tosecure portions of a cord of support band material to one another andthereby form a loop.

FIG. 30 is a top view of another exemplary locking member that can beused to secure portions of a cord of support band material to oneanother and thereby form a loop.

FIG. 31 is a perspective view of an exemplary adjustment tool (or pushertube) that can be used in connection with the locking member of FIG. 30.

FIG. 32 is a cross-sectional side view of the exemplary locking memberof FIG. 30.

FIG. 33 is a cross-sectional side view of the exemplary adjustment toolof FIG. 31.

FIGS. 34-37 are cross-sectional views illustrating how the exemplaryadjustment tool of FIG. 31 can be used to adjust, lock, and unlock theexemplary locking member of FIG. 30.

FIG. 38 is a cross-sectional perspective view of another exemplarylocking member that can be used to secure portions of a cord of supportband material to one another and thereby form a loop.

FIG. 39 is a cross-sectional perspective view of an exemplary pushertube that can be used in connection with the exemplary locking member ofFIG. 38.

FIGS. 40 and 41 are front views of an exemplary integrated deliverysystem for delivering embodiments of the disclosed support structures.In particular, FIG. 40 shows the delivery system before the supportstructure is deployed, and FIG. 41 shows the delivery system after thesupport structure is deployed.

FIGS. 42-46 are cross-sectional views of a patient's heart illustratinghow the delivery system of FIGS. 40 and 41 can operate to deploy thesupport structure of FIG. 1 to a desired position on the patient'saortic valve. In FIGS. 42-46, the support structure is deployed using atransfemoral approach.

FIG. 47 is a front view of another exemplary integrated delivery systemfor embodiments of the disclosed support structures.

FIGS. 48 and 49 are front views of an exemplary integrated deliverysystem for delivering embodiments of the disclosed support structures.In particular, FIG. 48 shows the delivery system before the supportstructure is deployed, and FIG. 49 shows the delivery system after thesupport structure is deployed.

FIGS. 50-55 are cross-sectional views of a patient's heart illustratinghow the delivery system of FIGS. 48 and 49 can operate to deploy thesupport structure of FIG. 1 to a desired position on the patient'saortic valve. In FIGS. 50-55, the support structure is deployed using atransapical approach.

FIG. 56 is a front view of an exemplary integrated delivery system fordelivering embodiments of the disclosed support structures. Inparticular, FIG. 56 shows the delivery system before the supportstructure is deployed.

FIGS. 57-61 are cross-sectional views of a patient's heart illustratinghow the delivery system of FIG. 56 can operate to deploy the supportstructure of FIG. 1 to a desired position on the patient's aortic valve.In FIGS. 57-61, the support structure is deployed using a transfemoralapproach.

FIG. 62 is a front view of another exemplary integrated delivery systemfor embodiments of the disclosed support structures.

FIG. 63 is a front view of an exemplary integrated delivery system fordelivering embodiments of the disclosed support structures. Inparticular, FIG. 63 shows the delivery system before the supportstructure is deployed.

FIGS. 64-70 are cross-sectional views of a patient's heart illustratinghow the delivery system of FIG. 63 can operate to deploy the supportstructure of FIG. 1 to a desired position on the patient's aortic valve.In FIGS. 64-70, the support structure is deployed using a transapicalapproach.

FIGS. 71A and 71B are front views of an exemplary delivery system havinga collapsible nose cone. In particular, FIG. 71A shows the deliverysystem before the support structure is deployed, and FIG. 71B shows thedelivery system after the support structure is deployed.

FIG. 72 is a perspective view of an alternative support stent designhaving spaced-apart support stent strut members.

FIG. 73 is a top view of the support stent shown in FIG. 72

FIG. 74 is a front view of a portion of the support stent shown in FIG.72.

FIG. 75 is a perspective view of another alternative support stentdesign.

FIG. 76 is a front view of a portion of an alternative support stentdesign having one or more projection extending from a support stentstrut member.

FIG. 77 is a perspective view of the support stent of FIG. 76 engagingleaflets of a native heart valve.

FIG. 78 is front view of a portion of another alternative support stentdesign having spaced-apart support stent strut members.

FIG. 79 is a front view of a portion of a further alternative supportstent design having spaced-apart support stent strut members.

FIG. 80 is a perspective view of the support stent of FIG. 79 engagingleaflets of a native heart valve.

FIG. 81 is a front view of a flattened-out alternative support stentdesign having a separate upper strut arms.

FIG. 82 is a front view of the support stent design of FIG. 81 after thesupport stent has been shape set so that the upper strut arms cross.

FIG. 83 is a perspective view of the support stent of FIG. 82 engagingleaflets of a native heart valve.

FIG. 84 is a front view of a portion of a flattened-out alternativesupport stent design having a upper strut arms that are connected by aconnecting member.

FIG. 85 is a front view of the support stent design of FIG. 84 after thesupport stent has been shape set so that the upper strut arms cross.

FIG. 86 is a perspective view of a support stent having six peaks andsix valleys.

FIG. 87 is a perspective view of a support stent that includes coversconfigured to at least partially cover the valleys of the support stent.

FIG. 88 is a perspective view of a support stent that includes tubularcovers configured to at least partially cover the body of the supportstent.

FIG. 89 is a perspective view of a support stent that includes abiocompatible coating and projections at the base of the valleys of thesupport stent.

FIG. 90 is a perspective view of a support stent that includes U-shapedprojections at the base of the valleys of the support stent.

FIG. 91 is a perspective view of a support stent that includesloop-shaped projections at the base of the valleys of the support stent.

FIG. 92 is a perspective view of a support stent that is at leastpartially covered by a multi-material cover.

FIG. 93 is a top view of the support stent of FIG. 92.

FIG. 94 is a bottom view of the support stent of FIG. 92.

FIG. 95 is a perspective view of a support stent that is covered by acover or coating having thicker portion at or near the bases of thevalleys of the support stent.

FIG. 96 is a perspective view of a support stent that includes anintegrated cover that covers the valleys of the support stent.

FIG. 97 is a perspective view of a support stent that includes anintegrated cover that covers the valleys of the support stent and hasportions that extend below the support stent.

FIG. 98 is a perspective view of another support stent that includes anintegrated cover that covers the valleys of the support stent and hasportions that extend below the support stent.

FIG. 99 is a side view of a support stent portion showing a portion of amulti-material cover that is used to cover the support stent.

FIG. 100 is a front view showing a portion of a support stent andhighlighting a location where thicker material for a cover can be used.

FIG. 101 is a front view of support stent portion that includes anembodiment of a mechanism for moving a cover into a final position onthe support stent when the support stent is expanded.

FIG. 102 is a side view of the support stent portion shown in FIG. 101when the support stent is in a compressed state.

FIG. 103 is a side view of the support stent portion shown in FIG. 101when the support stent is in a compressed state.

FIGS. 104-107 show a variety of different designs that can be used toform any of the disclosed support stents.

FIG. 108 is a perspective view of a support stent that includes coversconfigured to at least partially cover the inward-facing surface of thebody of the support stent.

FIG. 109 is a perspective view of another support stent that includescovers configured to at least partially cover the inward-facing surfaceof the body of the support stent.

FIG. 110 is a cross-sectional view of a patient's heart illustrating afirst exemplary embodiment of a leaflet stabilizing system.

FIG. 111 is a cross-sectional top view of the leaflet stabilizing systemof FIG. 110 showing a first orientation of leaflet stabilizer arms.

FIG. 112 is a cross-sectional top view of the leaflet stabilizing systemof FIG. 110 showing a second orientation of leaflet stabilizer arms.

FIG. 113 is a cross-sectional view of a patient's heart illustrating asecond exemplary embodiment of a leaflet stabilizing system.

FIG. 114 is a cross-sectional view of a patient's heart illustrating athird exemplary embodiment of a leaflet stabilizing system.

FIG. 115 is a perspective front view of the nose cone of the leafletstabilizing system of FIG. 114 with the stabilizer arms in an undeployedstate.

FIG. 116 is a perspective front view of the nose cone of the leafletstabilizing system of FIG. 114 with the stabilizer arms in a deployedstate.

FIG. 117 is a cross-sectional top view of an exemplary embodiment of thenose cone of FIG. 115.

FIG. 118 is a perspective front view of the nose cone of the leafletstabilizing system of FIG. 114 where the stabilizer arms have aleaf-shaped profile.

FIG. 119 is a perspective front view of a fourth exemplary embodiment ofa leaflet stabilizing system.

FIG. 120 is a cross-sectional view of the main catheter of the leafletstabilizing system of FIG. 119.

FIGS. 121-122 are cross-sectional views of a patient's heartillustrating how the leaflet stabilizing system of FIG. 119 can operateto stabilize the native valve leaflets.

FIG. 123 is a perspective front view of a fifth exemplary embodiment ofa leaflet stabilizing system.

FIG. 124 is a perspective front view of a first exemplary support stenthaving inward-facing projections.

FIG. 125 is a perspective front view of the support stent of FIG. 124coupled to the frame a prosthetic heart valve using the inward-facingprojections.

FIG. 126 is a cross-sectional side view of a patient's aortic valveshowing the support stent of FIG. 124 mechanically secured to the aorticvalve and to the frame of the prosthetic heart valve.

FIG. 127 is a perspective front view of a second exemplary support stenthaving inward-facing projections.

FIG. 128 is a partial side view of a third exemplary support stenthaving an inward-facing projection.

FIG. 129 is a partial side view of a portion of an exemplary supportstent having an increased diameter or width in its bottom portion.

FIG. 130 is a cross-sectional side view of a patient's aortic valveshowing the support stent of FIG. 129 frictionally secured to the aorticvalve and to the frame of a prosthetic heart valve.

FIG. 131 is a cross-sectional side view of a patient's aortic valveshowing an exemplary support stent having one or more interior ridges.The support stent in FIG. 131 is frictionally secured to the aorticvalve and to the frame of the prosthetic heart valve.

FIG. 132 is a perspective front view of a first exemplary support stenthaving extension portions that include inward-facing projections.

FIG. 133 is a perspective front view of the support stent of FIG. 132coupled to the frame of a prosthetic heart valve.

FIG. 134 is a bottom cross-sectional view of a patient's aortic valve inwhich the support stent of FIG. 132 is located and secures a prostheticheart valve.

FIG. 135 is a perspective front view of a second exemplary support stenthaving extension portions that include inward-facing projections.

FIG. 136 is a perspective front view of a third exemplary support stenthaving extension portions that include inward-facing projections.

FIG. 137 is a side view of a laid out, or unrolled, support stent withvalleys that are formed into extension portions having inward-facingprojections.

FIG. 138 is a perspective front view of a first system for deliveringthe support stent of FIG. 137.

FIG. 139 is a perspective front view of a second system for deliveringthe support stent of FIG. 138.

FIG. 140 is a perspective view of an exemplary prosthetic heart valvehaving an intermediate section with a greater diameter than otherportions of the heart valve.

FIG. 141 is a perspective view of an embodiment of a support stenthaving a generally hourglass-shaped frame.

FIG. 142 is a perspective view of an embodiment of a support stenthaving a frame with an outwardly bowed portion.

FIG. 143 is a cross-sectional side view of a patient's aortic valve inwhich the support stent of FIG. 142 frictionally secures the prostheticheart valve of FIG. 140 into position within the aortic valve.

FIG. 144 is a perspective view of an embodiment of a support stent inwhich one or more respective valleys of the support stent are shape setto form inward-projecting protrusions.

FIG. 145 is a cross-sectional side view of a patient's aortic valve inwhich the support stent of FIG. 147 frictionally secures the prostheticheart valve of FIG. 140 into position within the aortic valve.

FIG. 146 is a perspective view of an embodiment of a support stenthaving a flat ring shape.

FIG. 147 is a perspective view of an embodiment of a support stent inwhich one or more spherical members extend from a bottom edge of thesupport stent.

FIG. 148 is a perspective view of an embodiment of a support stent inwhich one or more inward-facing protrusions extend from portion of theframe support stent between a respective peak or valley of the frame.

FIG. 149 is a perspective view of an exemplary support stent secured toan exemplary prosthetic heart valve by clips that couple respectiveretaining arms of the support stent and the prosthetic heart valve toone another.

FIG. 150 is a cross-sectional side view of a patient's aortic valve inwhich a support stent coupled to a prosthetic heart valve at theirretaining arms is deployed.

FIG. 151 is a perspective view of an exemplary prosthetic heart valvehaving one or more leaflet retaining arms that extend longitudinallyalong the body of the prosthetic heart valve.

FIG. 152 is a perspective view of an exemplary prosthetic heart valvehaving one or more leaflet retaining arms that extend laterally acrossthe body of the prosthetic heart valve.

FIG. 153 is a cross-sectional side view of a patient's aortic valveillustrating an exemplary procedure for deploying a support stent arounda prosthetic heart valve using a dual system approach.

FIG. 154 is a perspective view of a modified version of the supportstent of FIG. 76 engaging leaflets of a native heart valve.

FIG. 155 is a perspective view of a support stent that is at leastpartially covered by a cover.

DETAILED DESCRIPTION

General Considerations

Disclosed below are representative embodiments of a support structure(sometimes referred to as a “support stent,” “support frame,” “supportband,” or “support loop”) that can be used to secure a prosthetic heartvalve within a native heart valve. For illustrative purposes,embodiments of the support structure are described as being used tosecure a transcatheter heart valve (“THV”) in the aortic valve or themitral valve of a heart. It should be understood that the disclosedsupport structure and THV can be configured for use with any other heartvalve as well. Also disclosed herein are exemplary methods and systemsfor deploying the support structure and corresponding THV. Although theexemplary methods and systems are mainly described in connection withreplacing an aortic or mitral valve, it should be understood that thedisclosed methods and systems can be adapted to deliver a supportstructure and THV to any heart valve.

For illustrative purposes, certain embodiments of the support structureare described as being used in connection with embodiments of theballoon-expandable THV described in U.S. Patent Application PublicationNos. 2007/0112422 (U.S. application Ser. No. 11/280,063) and2010/0049313 (U.S. application Ser. No. 12/429,040), which is herebyexpressly incorporated herein by reference. It should be understood,however, that this particular usage is for illustrative purposes onlyand should not be construed as limiting. Instead, embodiments of thedisclosed support structure can be used to secure a wide variety of THVsdelivered through a variety of mechanisms (e.g., self-expanding heartvalves, other balloon-expanding heart valves, and the like). Forinstance, any of the embodiments described in U.S. Pat. No. 6,730,118can be used with embodiments of the disclosed support structure. U.S.Pat. No. 6,730,118 is hereby expressly incorporated herein by reference.

The specification and claims sometimes refer to a first catheter being“advanced” relative to a second catheter. It should be noted that thislanguage not only encompasses situations where the first catheter isphysically moved by an operator relative to the second catheter but alsoencompasses situations where the second catheter is physically moved bythe operator relative to the first catheter (e.g., the second catheteris withdrawn over the first catheter, thereby causing the first catheterto be advanced relative to the second catheter). Likewise, thespecification and claims sometimes refer to a first catheter being“withdrawn” relative to a second catheter. It should be noted that thislanguage not only encompasses situations where the first catheter isphysically moved by an operator relative to the second catheter but alsoencompasses situations where the second catheter is physically moved bythe operator relative to the first catheter (e.g., the second catheteris advanced over the first catheter, thereby causing the first catheterto be withdrawn relative to the second catheter).

The described methods, systems, and apparatus should not be construed aslimiting in any way. Instead, the present disclosure is directed towardall novel and nonobvious features and aspects of the various disclosedembodiments, alone and in various combinations and sub-combinations withone another. The disclosed methods, systems, and apparatus are notlimited to any specific aspect, feature, or combination thereof, nor dothe disclosed methods, systems, and apparatus require that any one ormore specific advantages be present or problems be solved.

Although the operations of some of the disclosed methods are describedin a particular, sequential order for convenient presentation, it shouldbe understood that this manner of description encompasses rearrangement,unless a particular ordering is required by specific language set forthbelow. For example, operations described sequentially may in some casesbe rearranged or performed concurrently. Moreover, for the sake ofsimplicity, the attached figures may not show the various ways in whichthe disclosed methods, systems, and apparatus can be used in conjunctionwith other systems, methods, and apparatus.

Exemplary Embodiments for Replacing Aortic Valves

FIG. 1 is a perspective view showing an exemplary embodiment of asupport stent or frame 10. Support stent 10 has a generally annular ortoroidal body formed from a suitable shape-memory metal or alloy, suchas spring steel, Elgiloy®, or Nitinol. Desirably, the material fromwhich the support stent 10 is fabricated allows the support stent toautomatically expand to its functional size and shape when deployed butalso allows the support stent to be radially compressed to a smallerprofile for delivery through the patient's vasculature. In otherembodiments, however, the stent is not self expanding. In theseembodiments, and as more fully explained below, other mechanisms forexpanding the stent can be used (e.g., a balloon catheter).

In the illustrated embodiment, the projection of the support stent 10onto an x-y plane has a generally annular or toroidal shape. Theillustrated support stent 10 further defines a number of peaks andvalleys (or crests and troughs) along its circumference. For example,the support stent 10 is sinusoidally shaped in the z direction. In otherembodiments, the support stent 10 is shaped differently in the zdirection (e.g., sawtooth-shaped, ringlet-shaped, square-wave shaped, orotherwise shaped to include peaks and valleys).

The illustrated support stent 10 includes three peaks 20, 22, 24 andthree valleys 30, 32, 34. In the illustrated embodiment, the peaks 20,22, 24 are positioned above the valleys 30, 32, 34 in the z direction.In some embodiments, the peaks have greater radii than the valleys 30,32, 34, or vice versa. For instance, in some embodiments, the projectionof the support stent 10 onto an x-y plane forms a closed shape having avariable radius (e.g., a starfish shape).

The size of the support stent 10 can vary from implementation toimplementation. In particular embodiments, the support stent 10 is sizedsuch that the support stent can be positioned within the aorta of apatient at a location adjacent to the aortic valve, therebycircumscribing the aortic valve. Furthermore, in order to frictionallysecure a prosthetic heart valve in its interior, certain embodiments ofthe support stent 10 have a diameter that is equal to or smaller thanthe diameter of the prosthetic heart valve when fully expanded. Inparticular embodiments, for instance, the support stent can have aninner or outer diameter between 10 and 50 mm (e.g., between 17 and 28mm) and a height between 5 and 35 mm (e.g., between 8 and 18 mm).Furthermore, the thickness of the annular body of the support stent 10may vary from embodiment to embodiment, but in certain embodiments isbetween 0.3 and 1.2 mm.

FIG. 2 is a perspective view of the exemplary support stent 10positioned on the surface of an outflow side of a native aortic valveand further illustrates the shape of the support stent. In particular,it can be seen from FIG. 2 that the valleys 30, 32, 34 of the supportstent 10 are shaped so that they can be placed adjacent to commissures50, 52, 54 of the native leaflets 60, 62, 64 of the aortic valve.Furthermore, in the illustrated embodiment, the peaks 20, 22, 24 areshaped so that they generally approximate or mirror the size and shapeof the leaflets 60, 62, 64 but are slightly smaller and lower than theheight of the leaflets 60, 62, 64 at their tips when the aortic valve isfully opened. In other embodiments, the peaks 20, 22, 24 are oriented sothat they are adjacent to the commissures 50, 52, 54 of the nativeleaflets 60, 62, 64 and the valleys are opposite the apexes of theleaflets 60, 62, 64. The support stent 10 can be positioned in any otherorientation within the aortic valve as well.

It should be understood that the shape of the support stent or frame 10can vary from implementation to implementation. For example, in someembodiments, the support stent is not sinusoidal or otherwise shaped inthe z-plane. In other embodiments, the support stent is shaped as acylindrical band or sleeve. In general, the support stent or frame canbe any shape that defines an interior through which a THV can beinserted, thereby causing the native leaflets of the aortic valve (orother heart valve) to be pinched or securely held between the supportstent and the THV. Furthermore, the support stent can have a morecomplex structure. For example, although the support stent illustratedin FIGS. 1 and 2 is formed from a single annular member (or strut), thesupport stent can comprise multiple annular elements that interlock orare otherwise connected to one another (e.g., via multiple longitudinalmembers).

Returning to FIG. 1, the illustrated support stent 10 also includeretaining arms 21, 23, 25 that can be used to help position and deploythe support stent 10 into its proper location relative to the nativeaortic valve. The retaining arms 21, 23, 25 can have respectiveapertures 26, 27, 28. An exemplary deployment system and procedure fordeploying the support stent 10 using the retaining arms 21, 23, 25 aredescribed in more detail below. The support stent 10 can also have oneor more barbs located on its surface. Such barbs allow the support stent10 to be more securely affixed to the tissue surrounding the stent orthe leaflets of the aorta.

FIGS. 3 and 4 are side views of the distal end portion of an exemplarydelivery apparatus 100 for delivering the support stent 10 to itslocation adjacent the native aortic valve through a patient'svasculature. In particular, FIG. 3 shows the delivery apparatus when thesupport stent 10 is in a compressed, predeployed state, whereas FIG. 4shows the delivery apparatus when the support stent 10 is in adecompressed, deployed state. The delivery apparatus 100 comprises aguide catheter 102 having an elongated shaft 104, whose distal end 105is open in the illustrated embodiment. In other embodiments, the distalend 105 of the guide catheter 102 can be tapered into a conical shapecomprising multiple “flaps” forming a protective nose cone that can beurged apart when the support stent 10 and any interior catheters areadvanced therethrough. Furthermore, for illustrative purposes, the guidecatheter 102 is shown as being partially cut away, thus revealing thecatheters in its interior.

A proximal end (not shown) of the guide catheter 102 is connected to ahandle of the delivery apparatus 100. During delivery of a supportstent, the handle can be used by a clinician to advance and retract thedelivery apparatus through the patient's vasculature. In a particularuse, the delivery apparatus 100 is advanced through the aortic arch of apatient's heart in the retrograde direction after having beenpercutaneously inserted through the femoral artery. The guide cathetercan be configured to be selectively steerable or bendable to facilitateadvancement of the delivery system 100 through the patient'svasculature. An exemplary steerable guide catheter as can be used inembodiments of the disclosed technology is described in detail in U.S.Patent Application Publication No. 2007/0005131 (U.S. patent applicationSer. No. 11/152,288), which is hereby expressly incorporated herein byreference.

The delivery apparatus 100 also includes a stent delivery catheter 108positioned in the interior of the guide catheter 102. The stent deliverycatheter 108 has an elongated shaft 110 and an outer fork 140 connectedto a distal end portion of the shaft 110. The shaft 110 of the stentdelivery catheter 108 can be configured to be moveable axially relativeto the shaft 104 of the guide catheter 102. Furthermore, the shaft 110of the stent delivery catheter 108 can be sized so that its exteriorwall is adjacent to or in contact with the inner wall of the shaft 104of the guide catheter 102.

The delivery apparatus 100 can also include an inner catheter 118positioned in the interior of the stent deliver catheter 108. The innercatheter 118 can have an elongated shaft 120 and an inner fork 138secured to the distal end portion of the shaft 120. The shaft 120 of theinner catheter 118 can be configured to be moveable axially relative tothe shaft 104 of the guide catheter 102 and relative to the shaft 110 ofthe stent delivery catheter 108. Furthermore, the shaft 120 of the innercatheter 118 can be sized so that its exterior wall is adjacent to or incontact with the inner wall of the shaft 110 of the stent deliverycatheter 108. A guide wire (not shown) can be inserted into the interiorof the inner catheter 118. The guide wire can be used, for example, tohelp ensure proper advancement of the guide catheter 102 and itsinterior catheters through the vasculature of a patient.

As best shown in FIG. 5, a stent retaining mechanism is formed from theinner fork 138 attached to the distal end portion of the shaft 120 ofthe inner catheter 118 and the outer fork 140 attached to the distal endportion of the shaft 110 of the stent delivery catheter 108. The innerfork 138 includes a plurality of flexible inner prongs 141, 142, 143(three in the illustrated embodiment) at is distal end corresponding tothe retaining arms 21, 23, 25 of the support stent 10, and a headportion 144 at its proximal end. The outer fork 140 includes a pluralityof flexible outer prongs 145, 146, 147 (three in the illustratedembodiment) at its distal end corresponding to the retaining arms 21,23, 25 of the stent 10, and a head portion 148 at its proximal end. Thedistal end portions of the outer prongs 145, 146, 147 are formed withrespective apertures 155, 156, 157 sized to receive the retaining arms21, 23, 25.

FIG. 6 is a zoomed-in view of one of the retaining arms 21, 23, 25 as itinterfaces with corresponding prongs of the outer fork 140 and the innerfork 138. In this example, retaining arm 21 is shown, though it shouldbe understood that the retaining mechanism is similarly formed for theretaining arms 23, 25. The distal end portion of the outer prong 145 isformed with the aperture 155. When assembled, the retaining arm 21 ofthe stent is inserted through the aperture 155 of the prong 145 of theouter fork and the prong 141 of the inner fork is inserted through theaperture 26 of the retaining arm 21 so as to retain the retaining arm 21in the aperture 155.

Retracting the inner prong 141 proximally (in the direction of arrow152) to remove the prong from the aperture 26 allows the retaining arm21 to be removed from the aperture 155, effectively releasing theretaining arm from the retaining mechanism. For instance, the outerprong 145 and the retaining arm 21 can be formed such that when theinner prong 141 is withdrawn from the aperture 26, the outer prong 145flexes radially inward (downward in FIG. 7) and/or the retaining arm 21of the support stent flexes radially outward (upward in FIG. 7), therebycausing the retaining arm 21 to be removed from the aperture 155. Inthis manner, the retaining mechanism formed by the inner fork 138 andthe outer fork 140 create a releasable connection with the support stent10 that is secure enough to retain the support stent to the stentdelivery catheter 108 and to allow the user to adjust the position ofthe support stent after it is deployed. When the support stent 10 ispositioned at the desired location adjacent to the leaflets of theaortic valve, the connection between the support stent and the retainingmechanism can be released by retracting the inner fork 138 relative tothe outer fork 140, as further described below. In other embodiments,the function of the inner fork and the outer fork can be reversed. Forexample, the prongs of the inner fork can be formed with apertures sizedto receive the corresponding retaining arms of the support stent and theprongs of the outer fork can be inserted through the apertures of theretaining arms when the retaining arms are placed through the aperturesof the prongs of the inner fork.

As best shown in the exploded view in FIG. 5, the head portion 144 ofthe inner fork can be connected to the distal end portion of the shaft120 of the inner catheter 118. In the illustrated embodiment, forexample, the head portion 144 of the inner fork is formed with aplurality of angularly spaced, inwardly biased retaining flanges 154. Anend piece of the shaft 120 can be formed as a cylindrical shaft havingan annular groove 121. On the distal side of the annular groove 121, theshaft 120 can have a collar 122 with an outer diameter that is slightlygreater than the diameter defined by the inner free ends of the flanges154. Thus, the inner fork 138 can be secured to the end piece byinserting head portion 144 of the inner fork onto the end piece of theshaft 120 until the flanges 154 flex inwardly into the annular groove121 adjacent the collar 122, thereby forming a snap-fit connectionbetween the head portion 144 and the shaft 120. The head portion 144 canhave a proximal end that engages an annular shoulder 123 of the shaft120 that is slightly larger in diameter so as to prevent the headportion from sliding longitudinally along the shaft 120 in the proximaldirection.

The head portion 148 of the outer fork can be secured to a distal endportion of the shaft 110 of the stent delivery catheter 108 in a similarmanner. As shown in FIG. 5, the head portion 148 can be formed with aplurality of angularly spaced, inwardly biased retaining flanges 155. Anend piece of the shaft 110 can be formed as a cylindrical shaft havingan annular groove 111. On the distal side of the annular groove 111, theshaft 110 can have a collar 112 with an outer diameter that is slightlygreater than the diameter defined by the free ends of the flanges 155.Thus, the outer fork 140 can be secured to the end piece of the shaft110 by inserting the shaft 110 onto the head portion 148 until theflanges flex inwardly into the groove 111, thereby forming a snap-fitconnection between the head portion 148 and the shaft 110. The headportion 148 can have a proximal end that engages an annular shoulder 123of the shaft 110 that is slightly larger so as to prevent the headportion from sliding longitudinally along the shaft 110 in the proximaldirection.

In FIG. 3, the support stent 10 is shown in a radially compressed statein the interior of the elongated shaft 104 of the guide catheter 102. Inthe radially compressed state, the distance along the z axis between apeak and an adjacent valley of the support stent is greater than thedistance along the z axis between the peak and the adjacent valley whenthe support stent is in it uncompressed state. The distal end portion ofthe shaft 104 can also be referred to as a delivery sheath for the stent10. In this undeployed and compressed state, the prongs of the outerfork 140 and the inner fork 138 of the stent delivery catheter 108 andthe inner catheter 118 engage the retaining arms 21, 23, 25 of thesupport stent 10 in the manner described above with respect to FIGS. 5and 6. To deploy the support stent 10 in the illustrated embodiment(advance the stent from the delivery system), the stent deliverycatheter 108 and the inner catheter 118 are advanced toward the distalend 105 of the guide catheter 102 using one or more control handles ormechanisms (not shown) located at the proximal end of the guide catheter102. This action causes the support stent 10 to be advanced outwardlythrough the distal end 105 of the guide catheter 102 and expand into itsrelaxed, uncompressed state (shown, for example, in FIGS. 1 and 2).

FIG. 4 is a perspective view showing the support stent 10 after it hasbeen advanced from the distal end of the guide catheter 102. As seen inFIG. 4, the support stent 10 now assumes its relaxed, uncompressed shapebut remains connected to the outer fork 140 and the inner fork 138 atits retaining arms 21, 23, 25. In this configuration, the support stent10 can be rotated (in the clockwise or counter-clockwise directions) orrepositioned (in the proximal and distal directions and/or into adifferent position in the x-y plane) into a proper orientation adjacentto its intended target area. For example, the support stent 10 can bepositioned against the upper surfaces of leaflets of the aortic valve inthe manner illustrated in FIG. 2 while the support stent 10 remainsconnected to the delivery system 100 via the retaining arms 21, 23, 25.As more fully illustrated below in FIGS. 7-12, a prosthetic valve (e.g.,a THV) can be delivered to the aortic valve through a transapicalapproach (e.g., through the apex of the heart and through the leftventricle) and deployed within the native valve such that the prostheticvalve is secured in place by frictional engagement between the supportstent, the native leaflets, and the prosthetic valve.

In particular embodiments, the support stent 10 is shaped so that theTHV can be positioned in the interior of the support stent along withthe native leaflets of the aortic valve. More specifically, the supportstent 10 can be shaped such that the native leaflets become trapped orpinched between the support stent 10 and the exterior of the THV whenthe THV is installed. For instance, the diameter of the support stent 10can be equal to or smaller than the maximum diameter of the THV whenfully expanded, thus causing the THV to be frictionally fit to theleaflets of the aortic valve and the support stent 10. This friction fitcreates a solid foundation for the THV that is independent of the stateor condition of the leaflets in the aortic valve. For example, THVs aremost commonly used for treating aortic stenosis, a condition in whichthe leaflets of the aortic valve become hardened with calcium. Thehardened leaflets typically provide a good support structure foranchoring the THV within the aortic annulus. Other conditions may exist,however, in which it is desirable to implant a THV into the aortic valveand which do not result in a hardening of the leaflets of the aorticvalve. For instance, the support stent 10 can be used as a foundationfor a THV when treating patients with aortic insufficiency. Aorticinsufficiency results when the aortic annulus dilates such that theaortic valve does not close tightly. With this condition, the aorticannulus is larger than normal and would otherwise require a large THV.Using a support stent or frame (such as the support stent or frame 10),however, a smaller THV can be used, thereby making the THV deliveryprocess easier and safer. Furthermore, the use of a support stentprotects against displacement of the THV if there is any furtherdilation of the aortic valve.

A support stent can be used to secure a THV in any situation in whichthe aorta or aortic valve may not be in condition to help support theTHV and is not limited to cases of aortic insufficiency. For example, asupport stent 10 can be used in cases in which the aortic annulus is toodilated or in which the leaflets of the aorta are too weak or soft. Thesupport stent can be used to create an anchor for the THV, for instance,in cases in which the native leaflet tissue is too soft because ofexcess collagen in the aorta.

FIGS. 7-13 illustrate one exemplary procedure for deploying the supportstent and securing a THV to the support stent. In particular, FIGS. 7-8are cross-sectional views through the left side of a patient's heartshowing the acts performed in delivering the support stent 10 throughthe aortic arch to the aortic valve. FIGS. 9-13 are cross-sectionalviews through the left side of a patient's heart showing the actsperformed in deploying a THV 250 and having it engage the support stent10. In order to better illustrate the components of the delivery system100, the guide catheter 102 is shown partially cut away in FIGS. 7-13.For the sake of brevity, certain details concerning the delivery systemof the THV 250 are omitted. Additional details and alternativeembodiments of the delivery system for the THV 250 that may be used withthe support stent described herein are discussed in U.S. PatentApplication Publication No. 2007/0112422 (U.S. application Ser. No.11/280,063), which is hereby expressly incorporated herein by reference.

FIG. 7 shows the guide catheter 102 of the delivery system 100 as it isadvanced through the aortic arch 202 into a position near the surface ofthe outflow side of the aortic valve 210. The delivery system 100 can beinserted through the femoral artery of the patient and advanced into theaorta in the retrograde direction. FIG. 7 also shows the stent deliverycatheter 108, the inner catheter 118, and the support stent 10. In FIG.7, the support stent 10 is in its radially compressed, predeploymentstate. Also seen in FIG. 7 are the outer fork 140 and the inner fork138, which couple the radially compressed support stent 10 to the distalends of the stent delivery catheter 108 and the inner catheter 118,respectively.

FIG. 8 shows the support stent 10 after it has been advanced through thedistal end of the guide catheter 102 and assumes its final, uncompressedshape in a position above and adjacent to the aortic valve 210. Thesupport stent 10 can also be placed directly on the surface of theoutflow side of the aortic valve. FIG. 8 shows that the stent deliverycatheter 108 and the inner catheter 118 have been advanced though thedistal end of the guide catheter 102, thereby pushing the support stent10 out of the guide catheter and allowing it to expand into its naturalshape. In particular embodiments, the support stent 10 is rotated andpositioned as necessary so that the support stent generallycircumscribes the aortic valve and so that the peaks of the supportstent are aligned with the tips of the natural leaflets of the aorticvalve 210. Therefore, when the THV is inserted and expanded within theaortic valve 210, the leaflets of the aortic valve will engage at leastthe majority of the surface in the interior of the support stent 10.This alignment will create an overall tighter fit between the supportstent 10 and the THV. In other embodiments, the support stent 10 isrotated and positioned as necessary so that the peaks of the supportstent 10 are aligned with the commissures or other portions of theaortic valve. The position of the guide catheter 102 and the supportstent 10 relative to the aortic valve 210, as well as the position ofother elements of the system, can be monitored using radiopaque markersand fluoroscopy, or using other imaging systems such as transesophagealecho, transthoracic echo, intravascular ultrasound imaging (“IVUS”), oran injectable dye that is radiopaque.

Also seen in FIG. 8 are the prongs of the outer fork 140 and the prongsof the inner fork 138. In the exemplary procedure, the prongs of theouter fork 140 and the inner fork 138 remain secured to the supportstent 10 until the THV is deployed and frictionally engaged to thesupport stent. The inner and outer forks desirably form a connectionbetween the stent 10 and the delivery system that is secure and rigidenough to allow the clinician to hold the stent 10 at the desiredimplanted position against the flow of blood while the THV is beingimplanted.

In FIG. 8, the support stent 10 is self-expanding. In other embodiments,however, the support stent may not be self-expanding. In suchembodiments, the support stent can be made of a suitable ductilematerial, such as stainless steel. In addition, a mechanism forexpanding the support stent can be included as part of the deliverysystem 100. For example, the support stent can be disposed around aballoon of a balloon catheter in a compressed state. The ballooncatheter can have a shaft that is interior to the inner catheter 118.Because the stent 10 is not self-expanding, the distal end portion ofthe guide catheter 102 need not extend over the compressed supportstent. During delivery of the support stent, the support stent, ballooncatheter, inner catheter 118, and stent delivery catheter 108 can beadvanced from the distal end of the guide catheter 102. The balloonportion of the balloon catheter can be inflated, causing the supportstent to expand. The balloon portion can subsequently be deflated andthe balloon catheter withdrawn into the delivery system 100 to removethe balloon from the interior of the support stent while the supportstent remains connected to the inner catheter for positioning of thesupport stent. The delivery of the support stent otherwise proceeds asin the illustrated embodiment using the self-expanding support stent 10.

FIG. 9 shows an introducer sheath 220 passing into the left ventriclethrough a puncture 222 and over a guidewire 224 that extends upwardthrough the aortic valve 210. The clinician locates a distal tip 221 ofthe introducer sheath 220 just to the inflow side of the aortic valve210. The position of the introducer sheath 220 relative to the aorticvalve 210, as well as the position of other elements of the system, canbe monitored using radiopaque markers and fluoroscopy, or using otherimaging systems.

FIG. 10 shows the advancement of the balloon catheter 230 over theguidewire 224 and through the introducer sheath 220. Ultimately, as seenin FIG. 11, the THV 250 is located at the aortic annulus and between thenative aortic leaflets. FIG. 11 also illustrates retraction of theintroducer sheath 220 from its more distal position in FIG. 10.Radiopaque markers may be provided on the distal end of the introducersheath 220 to more accurately determine its position relative to thevalve 210 and balloon 232. In order to better illustrate the componentsof the delivery system for the THV, FIGS. 10-11 do not show the frontthird of the support stent 10 or the corresponding outer and inner prongof the outer fork and the inner fork, respectively. Furthermore, forpurpose of illustrating the relative position of the support stent 10 onthe THV 250, FIGS. 12-13 show the front third of the support stent 10and the front of the THV 250, but do not show the portions of the nativeheart valve that would be secured by the front of the support stent 10.It is to be understood, however, that a corresponding leaflet of thenative heart valve would be secured between the support stent 10 and theTHV 250.

Again, the precise positioning of the THV 250 may be accomplished bylocating radiopaque markers on its distal and proximal ends. In someembodiments, the clinician can adjust the position of the valve 250 byactuating a steering or deflecting mechanism within the balloon catheter230. Furthermore, the rotational orientation of the valve 250 can beadjusted relative to the cusps and commissures of the native aorticvalve by twisting the balloon catheter 230 from its proximal end andobserving specific markers on the valve (or balloon catheter) underfluoroscopy. One of the coronary ostia 280 opening into one of thesinuses of the ascending aorta is also shown in FIG. 11, and those ofskill in the art will understand that it is important not to occlude thetwo coronary ostia with the prosthetic valve 250.

FIG. 11 shows the THV 250 in its contracted or unexpanded state crimpedaround the balloon 232. When the clinician is satisfied of the properpositioning and rotational orientation of the valve 250, the balloon 232is expanded to engage the support stent 10 as seen in FIG. 12. Theengagement of the support stent 10 to the exterior of the THV 250pinches the leaflets of the aortic valve between the support stent andthe THV 250, and thereby secures the THV within the annulus of theaortic valve. Once secured into this position, the inner catheter 118 ofthe delivery system 100 can be retracted, thereby causing the prongs ofthe inner fork 138 to become disengaged from the retaining arms of thesupport stent 10. Once the prongs of the inner fork 138 are disengaged,the prongs of the outer fork 140 can be disengaged from the retainingarms by retracting the stent delivery catheter 108. Once disengaged fromthe support stent, the delivery system 100 can be retracted from theaortic arch and removed from the patient.

It should be noted that the valve 250 can take a variety of differentforms and may comprise an expandable stent portion that supports a valvestructure. The stent portion desirably has sufficient radial strength tohold the valve at the treatment site and to securely engage the supportstent 10. Additional details regarding balloon expandable valveembodiments that can be used in connection with the disclosed technologyare described in U.S. Pat. Nos. 6,730,118 and 6,893,460, both of whichare hereby expressly incorporated herein by reference.

Once the valve 250 is properly implanted, as seen in FIG. 13, theballoon 232 is deflated, and the entire delivery system including theballoon catheter 230 is withdrawn over the guidewire 224. The guidewire224 can then be withdrawn, followed by the introducer sheath 220.Ultimately, purse-string sutures 260 at the left ventricular apex can becinched tight and tied to close the puncture.

FIGS. 14-16 shows another embodiment of a support stent or frame 310that can be used to help secure a THV into the interior of a nativeheart valve, such as the aortic valve. In particular, FIG. 14 is aperspective view of the support stent 310, FIG. 15 is a top view of thesupport stent 310, and FIG. 16 is a side view of the support stent 310.Like support stent 10, support stent 310 has a generally annular ortoroidal body formed from a suitable shape-memory metal or alloy, suchas spring steel, Elgiloy®, or Nitinol. The support stent 310 is alsoradially compressible to a smaller profile and can self expand whendeployed into its functional size and shape. In other embodiments,however, the support stent 310 is not self expanding.

The support stent 310 includes a generally cylindrical main body portion320 and a rim portion 330. The support stent 310 can be a meshstructure, which can be formed, for example, from multiple elements inwhich approximately half of the elements are angled in a first directionand approximately half of the elements are angled in a second direction,thereby creating a criss-cross or diamond-shaped pattern. In theillustrated embodiment, the rim portion 330 has a greater diameter thanthe main body portion 320 and is formed as an extension at a bottomregion of the main body portion that is folded outwardly from the mainbody portion and back toward a top region of the main body portion. Therim portion 330 thus forms a U-shaped rim or lip around the bottomregion of the support stent 310. In general, the rim portion 330 isdesigned to have a diameter that is slightly larger than the walls ofthe aortic arch that surround the aortic valve. Thus, when the supportstent 310 is delivered to the aortic valve and deployed at the aorta,the rim portion 330 expands to engage the surrounding aorta wall andfrictionally secures the support stent 310. At the same time, the mainbody portion 320 defines an interior into which an expandable THV can beexpanded and which further engages the native leaflets of the aorticvalve. Thus, the main body portion 320 operates in the same manner asthe support stent 10 described above and illustrated in FIGS. 1-12,whereas the rim portion 330 of the support stent 310 operates to securethe support stent in place by engaging the walls of the aorta thatsurround the aortic valve.

As best seen in FIGS. 14 and 16, the support stent 310 further includesretaining arms 321, 322, 323 that can be used to help position anddeploy the support stent 310 into its proper location relative to thenative aortic valve. The retaining arms 321, 322, 323 can haverespective apertures 326, 327, 328. In general, the retaining arms 321,322, 323 are constructed and function in a similar manner as retainingarms 21, 23, 25 described above in the embodiment illustrated in FIGS.1-12.

FIGS. 17-18 illustrate one exemplary procedure for deploying the supportstent 310 and securing a THV 340 within an interior of the supportstent. In particular, FIGS. 17-18 are cross-sectional views through theleft side of a patient's heart showing the acts performed in deliveringthe support stent 310 through the aortic arch to the aortic valve. Forthe sake of brevity, certain details concerning the delivery system ofthe THV 340 are omitted. Additional details and alternative embodimentsof the delivery system for the THV 340 that may be used with the supportstent described herein are discussed in U.S. Patent ApplicationPublication No. 2008/0065011 (U.S. application Ser. No. 11/852,977) andU.S. Patent Application Publication No. 2007/0005131 (U.S. applicationSer. No. 11/152,288), which are hereby expressly incorporated herein byreference.

FIG. 17 shows an outer catheter 352 (which can be a guide catheter) of adelivery system 350 as it is advanced through the aortic arch 302 into aposition near the surface of the outflow side of the aortic valve 304.The delivery system 350 can be inserted through the femoral artery ofthe patient and advanced into the aorta in the retrograde direction.FIG. 17 also shows a stent delivery catheter 354, an inner catheter 356,and the support stent 310. Also seen in FIG. 17 are the outer fork 360and the inner fork 362, which couple the support stent 310 to the distalends of the stent delivery catheter 354 and the inner catheter 356,respectively.

More specifically, FIG. 17 shows the support stent 310 after it has beenadvanced through the distal end of the guide catheter 352 and assumesits final, uncompressed shape in a position adjacent to the aortic valve304. In order to better illustrate the components of the delivery systemfor the THV, FIGS. 17-18 do not show the entire front side of thesupport stent 310 or the corresponding valve leaflet that would besecured by the front side of the support stent 310. It is to beunderstood, however, that in practice the entire support stent 310 wouldexist and engage a corresponding leaflet of the native heart valve.

The support stent 310 can be positioned adjacent to the aortic valve 304so that the rim portion 330 of the support stent engages the wallssurrounding the aortic valve 304 and exerts an outward force againstthose walls, thereby securing the support stent 310 within the aorta.This positioning can be achieved, for example, by advancing the guidecatheter 352 to a position directly adjacent the aortic valve 304 whilethe stent delivery catheter 354 and the inner catheter 356 areundeployed and while the support stent 310 remains in its compressedstate. The guide catheter 352 can then be retracted while the stentdelivery catheter 354 and the inner catheter 356 are held in place,thereby allowing the support stent 310 to expand toward its naturalshape. As with the delivery system 100 described above, the position ofthe guide catheter 352 and the support stent 310 relative to the aorticvalve 304, as well as the position of other elements of the system, canbe monitored using radiopaque markers and fluoroscopy, or using otherimaging systems such as transesophageal echo, transthoracic echo, IVUS,or an injectable dye that is radiopaque.

Once the support stent 310 is positioned into the desired locationadjacent the aortic valve 304, the prongs of the inner fork 362 can bedisengaged from the corresponding apertures of the retaining arms of thesupport stent 310. For example, the inner catheter 356 can be retractedinto the interior of the stent delivery catheter 354, thereby releasingthe support stent 310 from the outer fork 360 and the inner fork 362.The delivery system 350 can then be retracted from the aorta and removedfrom the patient's body.

With the support stent 310 secured to the aortic valve, a THV (such asany of the THVs discussed above) can be introduced. In contrast to theprocedure illustrated in FIGS. 7-13, a delivery system having a deliverycatheter that is advanced through the patient's aorta can be used todeliver the THV. In other words, a transfemoral approach can be used.For instance, any of the exemplary systems and methods described in U.S.Patent Application Publication No. 2008/0065011 (U.S. application Ser.No. 11/852,977) or U.S. Patent Application Publication No. 2007/0005131(U.S. application Ser. No. 11/152,288) can be used with the supportstent 310. Alternatively, the transapical approach shown in FIGS. 7-13can be used.

FIG. 18 shows delivery system 380 comprising an outer catheter 382(which can be a guide catheter) and a balloon catheter 390 extendingthrough the guide catheter. The balloon catheter 390 has a balloon atits distal end on which the THV is mounted. As with the delivery system350, the delivery system 380 can be inserted through the femoral arteryof the patient and advanced into the aorta in the retrograde direction.FIG. 18 further shows a guidewire 392 that has been first inserted intothe patient's vasculature and advanced into the left ventricle. Thedelivery system can then be inserted into the body and advanced over theguidewire 392 until the THV is positioned within the interior of theaortic valve. As shown, the THV is not only in the interior of theaortic valve 304 but also in the interior of the main body portion ofthe support stent 310.

FIG. 18 shows the THV 340 in its contracted (or unexpanded) statecrimped around the balloon portion of the balloon catheter 390. When theclinician is satisfied of the proper positioning, the balloon of theballoon catheter 390 can be expanded such that the THV 340 expands andurges the native leaflets of the aortic valve against the support stent310, thereby securing the THV within the annulus of the aortic valve.Once the THV 340 is properly implanted, the balloon of the ballooncatheter 390 is deflated, and the entire delivery system 380 includingthe balloon catheter is withdrawn over the guidewire 392. The guidewire392 can then be withdrawn.

Other methods of delivering a support stent and THV to the aortic valveor any other heart valve are also possible. For example, in certainembodiments, the support stent and the THV are delivered surgically tothe desired heart valve (e.g., in an open-heart surgical procedure).Furthermore, in certain embodiments in which the support stent and THVare delivered surgically, non-compressible support stents and/or THVsare used.

Exemplary Embodiments for Replacing Mitral Valves

The mitral valve can also suffer from valve insufficiency, which may bedesirably treated through the implantation of a prosthetic valve. Aswith aortic valve insufficiency, mitral valve insufficiency often causesthe valve annulus to be dilated and the valve leaflets to be too soft toprovide reliable support for securing a prosthetic valve. Accordingly,and according to certain exemplary embodiments of the disclosedtechnology, it is desirable to use a support structure to help secure atranscatheter heart valve (“THV”) within a patient's mitral valve. Aswith the support stents and frames described above, the mitral valvesupport structure is desirably positioned on the outflow side of themitral valve. The THV can be inserted into the interiors of the nativemitral valve and the support structure and then expanded such that themitral valve leaflets are frictionally engaged between the exteriorsurface of the THV and the interior surface of the support structure.Alternatively, the support structure can be deployed after the THV ispositioned and expanded within the mitral valve. The diameter of thesupport structure can then be adjusted such that the valve leaflets arefrictionally engaged against the exterior of the THV. By using a supportstructure to secure the THV, a smaller THV can be used, thereby makingthe THV delivery process easier and safer. Furthermore, the use of asupport structure protects against displacement of the THV if there isany further dilation of the aortic valve. Moreover, when a supportstructure is used to secure the THV, the native leaflets function as asealing ring around the valve that prevents paravalvular leaks.

The support structure for the mitral valve can have a variety of shapes.For example, in some embodiments, the support structure has a sinusoidalshape as with the support stent 110, but in other embodiments does nothave a sinusoidal shape or is not otherwise shaped in the z-plane. Infurther embodiments, the support stent is shaped as a cylindrical bandor sleeve. The support frame can also have a more complex structure. Ingeneral, any of the shapes and materials used for embodiments of theaortic valve support structures described above can be used forembodiments of the mitral valve support structures and vice versa.

In one exemplary embodiment, the mitral valve support structure is madeof a suitable biocompatible material that can be delivered through oneor more delivery catheters and formed into a band or loop. For thisreason, the structure is sometimes referred to herein as a “supportband” or “support loop.” The biocompatible material may comprise, forexample, nylon, silk, polyester, or other synthetic biocompatiblematerial. The biocompatible material may alternatively comprise anatural material, such as catgut. In still other embodiments, thesupport structure is formed of a biocompatible shape-memory metal oralloy, such as spring steel, Elgiloy®, or Nitinol.

FIGS. 19-27 show one exemplary procedure for delivering a supportstructure to the mitral valve and having it secure a THV into itsdesired position within the mitral valve. In particular, FIGS. 19-24 arecross-sectional views through the left side of a patient's heart showingthe acts performed in delivering the support structure using atransapical approach. FIGS. 25-27 are cross-sectional views through theleft side of a patient's heart showing the acts performed in deploying aTHV and having it engage the mitral valve leaflets and the interior ofthe support structure. It should be noted that FIGS. 19-27 are schematicin nature and thus do not necessarily depict a precise representation ofthe delivery process. For example, the patient's ribcage is not shownfor illustrative purposes and the size of the sheaths used with thedelivery system have been altered somewhat in order to better illustratethe procedure. One of ordinary skill in the art, however, will readilyunderstand the range and types of sheaths and catheters that can be usedto implement the depicted procedure.

FIG. 19 shows an introducer sheath 400 inserted into the left ventricleof a patient's heart through a puncture 402. In particularimplementations, the introducer sheath 400 is positioned so that it isnot directly centered about the outflow side of the mitral valve, butrather is offset from the center. In particular, the introducer sheath400 can be positioned so that it is on the exterior side of the spaceenclosed by chordae tendineae 412. It should be noted that in FIGS.19-27, the chordae tendineae 412 of the left ventricle are onlypartially shown. It is to be understood, however, that the chordaetendineae 412 are respectively attached to each of the mitral valveleaflets and to the papillary muscles of the left ventricle. A cliniciancan locate a distal tip 401 of the introducer sheath 400 near theoutflow side of the mitral valve (e.g., within 1-10 millimeters).

FIG. 20 shows a first catheter delivery sheath 420 and a second catheterdelivery sheath 422 being advanced through the interior of theintroducer sheath 400. The introducer sheath 400 can define two or moreseparate lumens through which the first and the second catheter deliverysheaths 420, 422 can be inserted or can define a single lumensufficiently large to receive both the first and the second catheterdelivery sheaths 420, 422. The first and second catheter deliverysheaths 420, 422 can be shaped so that they arc outwardly from eachother when advanced out of the distal tip 401 of the introducer sheath400. For example, in the illustrated embodiment, the first and secondcatheter delivery sheaths 420, 422 have end regions 421, 423 that archabout 90 degrees (or some other amount, such as between 45-90 degrees)when they are in their natural state. The amount of arching may varyfrom implementation to implementation but is desirably selected so thatthe tips of the end portions 421, 423 are in approximately the sameplane. In other embodiments, the catheter delivery sheaths 420, 422 arenot used as part of the support structure delivery procedure.

In FIG. 21, a first loop delivery catheter 430 is advanced through theinterior of the first catheter delivery sheath 420 and extendedsubstantially around the exterior of one half of the chordae tendineae(e.g., the medial half of the chordae tendineae). Similarly, a secondloop deliver catheter 432 is advanced through the interior of the secondcatheter delivery sheath 422 and extended substantially around theexterior of the other half of the chordae tendineae (e.g., the lateralhalf of the chordae tendineae). The loop delivery catheters 430, 432 canbe steerable catheters having end regions that can be selectivelydeformed or arched by an operator. Such steerable catheters are wellknown in the art. The loop delivery catheters 420, 432 can additionallybe magnetic or have magnetic distal end portions. For example, in theillustrated embodiment, the first loop delivery catheter 430 has amagnetic distal end portion 431 with a first polarity, and the secondloop delivery catheter 432 has a magnetic distal end portion 433 with asecond polarity opposite the first polarity. As a result of theirmagnetization, the end portions 431, 433 are attracted to one anotherand will form a contiguous junction when in sufficient proximity to eachother. Other mechanisms for engaging the end portions 431, 433 to oneanother are also possible (e.g., a hook mechanism, an adhesive, anenlarged diameter of one end portion, and other such mechanisms). Whenthe end portions 431, 433 are engaged to one another, the first and thesecond loop delivery catheters 430, 432 form a single interior or lumenthrough which a support band material can be advanced. Furthermore, whenthe end portions 431, 433 are engaged to one another, the first and thesecond loop delivery catheters 430, 432 create a partial loop thatcircumscribes the chordae tendineae.

FIG. 22 shows the magnetic distal end portions 431, 433 after the firstand second loop delivery catheters 430, 432 are arched around thechordae tendineae and after the distal end portions have beenmagnetically engaged to one another. In this configuration, a cord 440of biocompatible material can be advanced through the interior of one ofthe loop delivery catheters 430, 432 and into the interior of the otherone of the loop delivery catheters. As used herein, the term “cord”refers to a slender length of material that can be formed from a singlestrand, fiber, or filament, or can comprise multiple strands, fibers, orfilaments. In one particular implementation, an end 442 of the cord 440can be advanced from a proximal end of the first loop delivery catheter430, through the interior of the first loop delivery catheter, throughthe junction formed by the distal end portions 431, 433, and through theinterior of the second loop delivery catheter 432 until it appears onthe proximate end of the second loop delivery catheter 432. In oneparticular embodiment, the cord 440 is a guidewire (e.g., a guidewiremade of stainless steel or other suitable metal). The guidewire can thenbe attached to another cord of biocompatible material used to form thesupport band and pulled through the interior of the first and the secondloop delivery catheters 430, 432, thereby positioning the cord ofbiocompatible material around the chordae tendineae in a partial loop.With the cord of biocompatible material delivered around the chordaetendineae, the first and second loop delivery catheters 430, 432 and thefirst and second catheter delivery sheaths 420, 422 can be retractedfrom the introducer sheath 400.

FIG. 23 shows a cord 443 of biocompatible material used to form thesupport band positioned around the chordae tendineae after the first andsecond loop delivery catheters 430, 432 and the first and secondcatheter delivery sheaths 430, 422 have been withdrawn. In FIG. 23, asheath 450 is inserted over both ends of the cord 443 and over a firstportion 444 and a second portion 446 of the cord 443, which run throughthe length of the sheath 450.

As shown in FIG. 24, a locking member 460 can be advanced over the firstand second portions 444, 446 of the cord 443 and into the leftventricle. The locking member 460 can be advanced, for example, by apusher tube 462 that pushes the locking member 460 over the portions444, 446 of the cord 440. In one particular embodiment, the lockingmember 460 includes lumens or other openings configured to receive eachof the two portions 444, 446 and permits movement along the portions444, 446 in only a single direction. In certain other embodiments, thelocking member 460 can be unlocked from the portions 444, 446 of thecord 440 and advanced in both directions along the cord 440. In theillustrated embodiment, the pusher tube 462 is further configured tosever the portions of the cord 440 that extend through a proximal sideof the locking member 460, thereby releasing a support band 441 formedby the locking member 460 and the loop-shaped portion of the cord 443from the pusher tube 462. As more fully shown in FIG. 25, the pushertube 462 can further be formed of a shape memory material or include adeflection mechanism that allows the pusher tube to have an arched shapetoward its distal end. On account of this arched shape, the pusher tube462 can be used to better position the support band 441 formed by theloop-shaped portion of the cord 443 and the locking member 460 adjacentto the outflow side of the mitral valve such that the native leaflets ofthe mitral valve open into an interior of the support band 441.

As shown in FIG. 25, the sheath 450 can be withdrawn from the introducersheath 400 once the locking member 460 and the pusher tube 462 areadvanced into the left ventricle. A balloon catheter 470 can be advancedthrough the introducer sheath 400 and into the interior of the mitralvalve 410 of the patient. Although not shown in the illustratedembodiment, the balloon catheter may be guided by a guidewire into thecenter of the mitral valve. Ultimately, and as seen in FIG. 25, aballoon portion 472 of the balloon catheter 470 around which a THV 480is crimped can be located within the mitral annulus. Radiopaque markersor other imaging enhancers may be provided on the distal end of theintroducer sheath 400 and the balloon catheter 470 to more accuratelydetermine the position of the THV 480 relative to the native valve 410.In some embodiments, a clinician can adjust the position of the THV 480by actuating a steering or deflecting mechanism within the ballooncatheter 470.

As also shown in FIG. 25, the locking member 460 and the pusher tube 462can be positioned so as not to interfere with the balloon catheter 470.Furthermore, with the THV 480 properly positioned within the mitralvalve 410, the pusher tube 462 can be used to position the support band441 formed by the loop-shaped remaining portion of the cord 443 aroundthe native valve leaflets of the mitral valve. Radiopaque markers orother suitable imaging enhancers can be provided on the pusher tube 462,the locking member 460, and/or the loop-portion of the cord to allow forthe proper positioning of the support band 441 relative to the valveleaflets. With the THV 480 in its desired position, the balloon portion472 of the balloon catheter 470 can be inflated, thereby expanding theTHV 480 against the native valve leaflets and causing the leaflets tofrictionally engage the interior surface of the support band 441. Thisexpansion secures the THV 480 to the native valve leaflets. In otherwords, the expansion pinches the native leaflets of the mitral valvebetween the support band 441 and the THV 480, and thereby secures theTHV within the annulus of the mitral valve.

As shown in FIG. 26, with the THV 480 secured against the native mitralvalve leaflets and the support band 441, the balloon portion 472 of theballoon catheter 470 can be deflated and the balloon catheter withdrawnfrom the introducer sheath 400. The pusher tube 462 can then bedisengaged from the loop 441. For example, the pusher tube 462 cancomprise a cutting element at its distal end that can be activated bythe clinician from the proximal end. An example of one suitable cuttingelement is shown below with respect to FIG. 39. Alternatively, aseparate cutting device (e.g., a cutting catheter or catheter having acontrollable cutting element) can be inserted through the introducersheath 400 and used to cut the portions of the cord 443 that extendthrough the proximal side of the locking member 460 and do not form partof the support band 441.

FIG. 27 shows the THV 480 secured within the native mitral valve afterthe support band 441 has been released from the pusher tube 462 and thepusher tube has been retracted from the introducer sheath 400. It shouldbe noted that the THV 480 can take a variety of different forms and maycomprise an expandable stent portion that supports a valve structure.The stent portion desirably has sufficient radial strength to hold thevalve at the treatment site and to securely engage the support band 441.

It will be understood by those of ordinary skill in the art that theabove-described loop deployment technique can be modified in a number ofmanners without departing from the disclosed technology. For example, insome embodiments, the THV is delivered and expanded into the mitralvalve before the support band is delivered to the left ventricle. Inthese embodiments, the THV can be temporarily secured within the mitralvalve. For example, the THV can be temporarily secured to the mitralvalve using one or more anchoring members on the exterior of the THV(e.g., anchoring members having a main body and one or more hook-shapedor umbrella-shaped barbs). The THV can also be temporarily securedwithin the mitral valve through the use of one or more spring-loadedclamps, rivets, clasps, or other such fastening mechanisms. With the THVtemporarily secured, the support band can be delivered around the nativeleaflets as described above and the diameter of the support band reduceduntil a desired frictional fit is created between the support band, theleaflets, and the THV. Any of the locking members described herein thatallow the diameter of the support band to be adjusted can be used toachieve the desired diameter.

Further, although the delivery method shown in FIGS. 19-27 uses atransapical approach, a delivery system adapted for introduction throughthe patient's aortic arch can alternatively be used. FIG. 28 shows anexample of such a delivery system 500. In particular, FIG. 28 shows thedelivery system 500 after a delivery catheter has been advanced throughthe aortic arch to a position adjacent the aortic valve and as a firstloop deliver catheter 510 and a second loop deliver catheter 512 aredeployed through the distal end of a delivery catheter 502. As with theprocedure described above, the first and second loop delivery catheters510, 512 can be steerable and comprise magnetic distal end portions thatallow the catheters 510, 512 to engage one another on a distal side ofthe chordae tendineae, thereby forming a delivery lumen through whichbiocompatible material for the support band or loop can be deployed.Also shown in FIG. 28 is an introducer sheath 520 and a balloon deliverycatheter 522 for deploying a THV 524. Besides the adaptations for aorticdelivery, the delivery procedure can otherwise be substantially similaror identical to the procedure shown in FIGS. 19-27.

Still other delivery variations are possible. For instance, the supportband may be formed of a shape-memory material that assumes a C-shapewhen not acted on by any external forces. The support band can befurther configured such that one end of the C-shaped member is hollowand has a slightly larger diameter than the opposite end. To deliver theC-shaped support band, the support band can be stretched into a linearform and advanced through a delivery catheter (e.g., using a pusherelement). In particular, the distal end of the delivery catheter can bepositioned adjacent the chordae tendineae such that when the supportband is advanced out of the distal end, it wraps around the chordaetendineae. After the support band is deployed from the distal end of thedelivery catheter, a clamping device that is designed to engage theC-shaped support band and urge the ends of the support band together canbe inserted into the heart (e.g., through the delivery catheter, theintroducer sheath, or through a separate catheter). The clamping devicecan be used to urge one end of the support band into the hollow oppositeend of the band. The ends can be crimped so that the support band formsa ring-shaped support band (e.g., using the clamping device or otherdevice). In other embodiments, the hollow end of the support band cancomprise a shoulder that engages an angled collar on the other end ofthe support band when the ends are urged together, thereby form asnap-fit connection. With the ends of the support band secured to oneanother, the support band can be positioned around the native leafletsof the mitral valve (e.g., using the clamping device or otherpositioning device) as a balloon catheter delivers a THV. Uponexpansion, the THV will pinch the native valve leaflets between theouter surface of the THV and the interior surface of the support band,thereby securing the THV within the mitral valve.

In still another embodiment, the support band includes one or moreclamping or fastening devices that can be used to clamp or fasten thesupport band to the native leaflets of the mitral leaflets. For example,the clamping or fastening devices can comprise spring-loaded clamps,anchoring members having one or more hook or umbrella-shaped barbs,clasps, or other such clamping or fastening mechanisms. In thisembodiment, the support band still has a substantially fixed diametersuch that when the THV is expanded into the interior of the mitralvalve, the THV causes the native valve leaflets to be pinched againstthe interior surface of the support band, thereby securing the THVwithin the mitral valve. In still other embodiments, the THV itself caninclude one or more clamping or fastening devices designed to clamp orfasten the THV to the native leaflets of the mitral valve (e.g., any ofthe clamping or fastening mechanisms described above). In thisembodiment, the THV can be secured directly to the native leafletswithout the use of a support band or other support structure.

FIG. 29 shows one exemplary embodiment of a locking member that can beused for locking member 460 shown in FIGS. 19-27. In particular, FIG. 29shows locking member 600, which can be a clamp, such as an adjustable,C-shaped clamp with interlocking teeth around a portion of the clamp.The locking member 600 has two arms 610, 612, each formed withinterlocking teeth 620, 622. Interlocking teeth 620, 622 are configuredto lock the clamp in one or more positions of varying circumference whenpressure is applied to the two arms 610, 612 and pushes the armstogether. Referring to FIG. 23, the cord portions (such as portions 446,446) can be inserted into the interior 630 of the locking member 600.The arms 610, 612 can be pushed together and tightened so that theportions 444, 446 are secured in place (e.g., using a clamping deviceinserted into the left ventricle through the introducer sheath or usingthe pusher tube 462 modified to include a clamping mechanism). Theinterior 630 can additionally have grooves to increase the friction anddecrease the slippage between the locking member 600 and the portions ofthe cord secured therein.

FIGS. 30-37 depict another exemplary embodiment of a locking member thatcan be used for locking member 460 shown in FIGS. 19-27. In particular,FIGS. 30-37 show an adjustable locking member 700, which can be attachedto two portions of a cord, thereby forming the support band. As bestseen in FIGS. 30 and 32, the adjustable locking member 700 comprises atapered, plastic pin 710 that fits into a tapered, plastic snap ring720. When pin 710 and ring 720 are locked together, the adjustablelocking member 700 is prevented from moving relative to the portions ofthe cord that are captured within the adjustable locking member 700(e.g., cord portions 702, 704 in FIG. 30).

FIG. 31 illustrates an exemplary pusher tube (or adjustment catheter)730 that can be used to introduce, position, and lock the adjustablelocking member 700 in a desired position. The exemplary pusher tube 730in the illustrated configuration has a fork member 732, an unlockingpush member 734 that is extendable through the fork member 732, and alocking push member 736 that is extendable over the unlocking pushmember 734. Fork member 732 is configured so that it can move theadjustable locking member 700 over the cord portions to which it isconnected. In particular, fork member 732 can engage the adjustablelocking member 700 when it is positioned along the cord portions (butnot yet in a locked position) such that by moving the pusher tube 730 inone direction along the length of the cord portions, adjustable lockingmember 700 is also moved. By moving the adjustable locking member 700 inthis manner, the effective diameter of the support band formed by thecord and the adjustable locking member 700 can be modified.

Push members 734, 736 are slidably movable relative to each other andthe fork member 732 to effect locking and unlocking of the adjustablelocking member 700, as further described below. The unlocking pushmember 734 unlocks the adjustable locking member 700 from the lockedposition and the locking push member 736 locks the adjustable lockingmember 700 from the unlocked position.

FIG. 32 depicts the adjustable locking member 700, according to oneembodiment, in more detail. The pin 710 comprises pin slots or holes 712(which accept the cord portions) and locking members or flanges 714(which extend outward to secure the pin to the ring in a lockedposition). Ring 720 comprises ring slots or holes 722 (which accepts thecord portions) and pin receiving hole 724 (which receives the pin tosecure the pin to the ring in a locked position). The locking members714 are deformable to allow the pin member to be inserted throughoutring member and form a snap-fit connection sufficient to hold the ringmember on the pin member.

FIGS. 33-37 depict the relationship between the adjustable lockingmember 700 and the pusher tube 730, according to one embodiment, andtheir functions relative to one another. As discussed above, the pushertube 730 comprises fork member 732, unlocking push member 734, andlocking push member 736. FIG. 33 shows the pusher tube 730 in moredetail. Both the unlocking push member 734 and the locking push member736 are slidably movable within the pusher tube 730 along thelongitudinal direction identified by the arrows shown in FIG. 33. Theunlocking push member 734 is desirably a solid member that is sized tofit within the locking push member 736, which is desirably cylindricalwith a longitudinally extending hollow section or lumen for receivingthe unlocking push member 734.

FIG. 34 shows the adjustable locking member 700 with the pin 710 and thering 720 locked together. In the locked position, the cord portions 702,704 pass inside the ring 720 and around the pin 710 (through the ringholes and pin holes) and are captured between these two components. Thecord portions 702, 704 are held in place relative to each other, and thepin 710 and the ring 720 are held in place relative to the cord portions702, 704 by the friction created at the surface interfaces.

Referring to FIGS. 35 and 36, to unlock the adjustable locking member700, the fork member 732 is inserted between the pin 710 and the ring720, and the unlocking push member 734 is extended from the pusher tube730 to push the pin 710 and the ring 720 apart. The fork member 732holds the ring 720 in place, while the unlocking push member 734 applieslongitudinal pressure against the tip of the pin 710, forcing it out ofthe ring 720. The unlocking push member 734 is desirably sized so thatit can fit at least partially through the pin receiving hole 724 toassist in unlocking the pin 710 and the ring 720 from one another. Oncethe pin 710 and the ring 720 are separated, the adjustable lockingmember 700 can be moved relative to the cord portions 702, 704 in orderto adjust the diameter of the support band formed by the cord portions702, 704.

Referring to FIG. 37, the manner in which the pusher tube 730 can beused to secure the pin 710 and the ring 720 together is shown. The forkmember 732 is placed at the far (distal) end of the pin 710 and thelocking push member 736 is extended from the pusher tube 730. Thelocking push member 736 is configured with a cylindrical surface that issized to mate with the area of the ring 720 that surrounds the pinreceiving hole. While the fork member 732 holds the pin 710 in place,the locking push member 736 forces the ring 720 onto the pin 710 andlocks the pin and the ring together. Once the adjustable locking member700 is locked, the frictional engagement of the adjustable lockingmember with the cord portions maintains the position of the adjustablelocking member relative to the cord portions 702, 704. The three-pointconnection system described above permits a clinician to perform fineadjustments of the diameter of the support band around the chordaetendineae and around the outflow side of the native leaflets of themitral valve.

FIGS. 38-39 depict another exemplary embodiment of a locking member thatcan be used for locking member 460 shown in FIGS. 19-27. In particular,FIG. 38 shows an adjustable locking member 900 having a generallycylindrical body with two lumens (or apertures) 910, 912 formed thereinthat extend from a top surface 902 to a bottom surface 904 of the body.In the illustrated embodiment, and as best seen in the cut-away portionof FIG. 38 showing the lumen 912, the interior of the lumens 910, 912comprises a plurality of teeth (or collars) 920, 922 that are angledtoward the bottom surface 904. The teeth 920 can have some flexibilityand be formed to allow a cord portion, such as cord portion 930 or cordportion 932, to slide through the lumens 910, 912 in a first direction,but not in an opposite second direction. In other words, the teeth 920,922 of the adjustable locking member 900 allow for one-way movement ofthe locking member 900 along the cord portions 930, 932. In this way,the adjustable locking member 900 can be used to securely form thesupport band and allows for the diameter of the support band to beadjusted to its desired size.

FIG. 39 shows an exemplary embodiment of a pusher tube 950 that can beused with the adjustable locking member 900 (e.g., the pusher tube 950can be used as the pusher tube 462 shown in FIGS. 19-27). The exemplarypusher tube 950 includes lumens 960, 962 through which the cord portions930, 932 can extend. In a particular embodiment, the lumens 960, 962have a sufficiently large diameter and a smooth interior that allows thecord portions 930, 932 to more easily slide therethrough. In theillustrated embodiment, the pusher tube 950 further includes a rotatableblade 970 at its distal end 902. The rotatable blade 970 can berotatable about a central axis of the pusher tube 950 and connected toan interior rod member 972 that extends through a central lumen of thepusher tube 950. A handle (not shown) can be attached to the interiorrod member 972 at its proximal end and allow for an operator to manuallyrotate the rotatable blade 970 in order to sever the pusher tube 950from the adjustable locking member 900.

Other methods of delivering a support band and THV to the mitral valveor any other heart valve are also possible. For example, in certainembodiments, the support band and the THV are delivered surgically tothe desired heart valve (e.g., in an open-heart surgical procedure).Furthermore, in certain embodiments in which the support band and THVare delivered surgically, non-compressible THVs are used.

Exemplary Embodiments for Replacing an Aortic Valve Using IntegratedDelivery Systems

In this section, embodiments of integrated delivery systems capable ofdelivering both a prosthetic valve and a support stent to a desiredlocation are described. The integrated delivery systems can help reducethe trauma experienced by a patient during valve implantation since thesystems can use a single point of entry. For example, the embodimentsshown in FIGS. 40-47 and 56-62 can be used to perform a transfemoralvalve delivery, whereas the embodiments shown in FIGS. 48-55 and 63-70can be used to perform a transapical valve delivery.

FIGS. 40 and 41 are front views of the distal end portion of anexemplary delivery system 4000 for delivering the support stent 10 toits location adjacent the native aortic valve through a patient'svasculature (e.g., transfemorally). In particular, FIG. 40 shows thedelivery system when the support stent 10 is in a compressed,predeployed state, whereas FIG. 41 shows the delivery system when thesupport stent 10 is in a decompressed, deployed state. The deliverysystem 4000 comprises a main catheter 4002 (which can be a steerableguide catheter) having an elongated shaft 4004, whose distal end 4005 isopen. In other embodiments, the distal end 4005 of the main catheter4002 can be tapered (e.g., tapered into a conical shape comprisingmultiple “flaps” forming a protective nose cone that can be urged apartwhen the support stent 10 and any interior catheters are advancedtherethrough or tapered into a conically shaped solid profile with onlya thru lumen for the placement of a guidewire). The nose cone can beconfigured to have a variety of different profiles, including, but notlimited to, a bullet-tipped, blunt-tipped, triangular, or other suchtapered profile. Furthermore, for illustrative purposes, the maincatheter 4002 is shown as being partially cut away, thus revealing thecatheters in its interior.

A proximal end (not shown) of the main catheter 4002 is connected to ahandle of the delivery system 4000. During delivery of a support stent,the handle can be used by a clinician to advance and retract thedelivery system through the patient's vasculature. In a particular use,the delivery system 4000 is advanced through the aortic arch of apatient's heart in the retrograde direction after having beenpercutaneously inserted through the femoral artery. The main cathetercan be configured to be selectively steerable or bendable to facilitateadvancement of the delivery system 4000 through the patient'svasculature. An exemplary steerable catheter as can be used inembodiments of the disclosed technology is described in detail in U.S.Patent Application Publication No. 2007/0005131 (U.S. patent applicationSer. No. 11/152,288), which is hereby expressly incorporated herein byreference.

The delivery system 4000 also includes a stent delivery outer catheter4008 positioned in the interior of the main catheter 4002. The stentdelivery outer catheter 4008 has an elongated shaft 4010 and an outerfork 4040 connected to a distal end portion of the shaft 4010. The shaft4010 of the stent delivery outer catheter 4008 can be configured to bemoveable axially relative to the other shafts of the delivery system4000 (e.g., using a handle or lever (such as a lockable handle or lever)located at or near a proximal end of the delivery system 4000 as isknown in the art). Furthermore, the shaft 4010 of the stent deliveryouter catheter 4008 can be sized so that its exterior wall is adjacentto or in contact with the inner wall of the shaft 4004 of the maincatheter 4002.

The delivery system 4000 can also include a stent delivery innercatheter 4018 positioned in the interior of the stent deliver outercatheter 4008. The stent delivery inner catheter 4018 can have anelongated shaft 4020 and an inner fork 4038 secured to the distal endportion of the shaft 4020. The shaft 4020 of the inner catheter 4018 canbe configured to be moveable axially relative to the other shafts of thedelivery system 4000 (e.g., using a handle or lever (such as a lockablehandle or lever) located at or near a proximal end of the deliverysystem 4000 as is known in the art). Furthermore, the shaft 4020 of theinner catheter 4018 can be sized so that its exterior wall is adjacentto or in contact with the inner wall of the shaft 4010 of the stentdelivery outer catheter 4008.

The delivery system 4000 further includes a prosthetic valve deliverycatheter 4060. The prosthetic valve delivery catheter 4060 comprises anelongated shaft 4062 positioned in the interior of the stent deliveryinner catheter 4018 and a balloon portion 4064 located near a distal endof the elongated shaft 4062. The shaft 4062 of the prosthetic valvedelivery catheter 4060 can be configured to be moveable axially relativeto the other shafts of the delivery system 4000 (e.g., using a handle orlever (such as a lockable handle or lever) located at or near a proximalend of the delivery system 4000 as is known in the art). Furthermore,the shaft 4062 of the prosthetic valve delivery catheter 4060 can besized so that its exterior wall is adjacent to or in contact with theinner wall of the shaft 4020 of the stent delivery inner catheter 4018.In the illustrated embodiment, a nose cone 4050 is attached to thedistal end of the balloon portion 4064, though in other embodiments, theelongated shaft 4062 can continue beyond the balloon portion and thenose cone can be attached to a distal end of the elongated shaft. Instill other embodiments, the nose cone 4050 is absent. A prostheticvalve 4070 (e.g., a THV) is positioned around the balloon portion 4064in a crimped or unexpanded state. The prosthetic valve 4070 can be anysuitable expandable prosthetic heart valve, such as those described inU.S. Patent Application Publication No. 2007/0112422 (U.S. applicationSer. No. 11/280,063), which is expressly incorporated herein byreference. The prosthetic valve delivery catheter 4060 can include oneor more fluid lumens (not shown) through which a suitable liquid or gascan be inserted to cause the balloon portion 4064 to expand, therebyexpanding the prosthetic valve 4070 into its expanded state. In otherwords, the prosthetic valve delivery catheter 4060 can be a ballooncatheter. The one or more fluid lumens of the prosthetic valve deliverycatheter 4060 can comprise an annular lumen or a non-concentric (oroffset) lumen that allows a further lumen to be defined within theprosthetic valve delivery catheter 4060. In certain embodiments, theprosthetic valve delivery catheter 4060 itself comprises multiplecatheters, including an outer catheter to which the balloon is attachedand an inner catheter that is coupled to the balloon only at theballoon's distal end. With such a design, fluid can be inserted in theannular space between the outer catheter and the inner catheter.Furthermore, the prosthetic valve delivery catheter 4060 can define aguidewire lumen through which a guide wire 4080 can be inserted. Theguide wire can extend through a distal end 4051 of the nose cone 4050and can be used, for example, to help ensure proper advancement of themain catheter 4002 and its interior catheters through the vasculature ofa patient. In FIG. 40, the prosthetic valve 4070 is shown as not beingenclosed by the main catheter 4002. However, in other embodiments, themain catheter 4002 can be configured to enclose the prosthetic valve4070 during insertion of the delivery system 4000 into the vasculatureof the patient.

In FIG. 40, the support stent 10 is shown in a radially compressed statein the interior of the elongated shaft 4004 of the main catheter 4002.In the radially compressed state, the distance along the z axis betweena peak and an adjacent valley of the support stent is greater than thedistance along the z axis between the peak and the adjacent valley whenthe support stent is in it uncompressed state. The distal end portion ofthe shaft 4004 can also be referred to as a delivery sheath for thestent 10. In this undeployed and compressed state, the prongs of theouter fork 4040 and the inner fork 4038 of the stent delivery outercatheter 4008 and the stent delivery inner catheter 4018 engage theretaining arms 21, 23, 25 of the support stent 10 in the mannerdescribed above with respect to FIGS. 5 and 6. To deploy the supportstent 10 in the illustrated embodiment (advance the stent from thedelivery system), the stent delivery outer catheter 4008 and the stentdelivery inner catheter 4018 are advanced toward the distal end 4005 ofthe main catheter 4002 using one or more control handles or mechanisms(not shown) located at the proximal end of the main catheter 4002. Thisaction causes the support stent 10 to be advanced outwardly through thedistal end 4005 of the main catheter 4002 and expand into its relaxed,uncompressed state (shown, for example, in FIGS. 1 and 2).

FIG. 41 is a front view showing the support stent 10 after it has beenadvanced from the distal end of the main catheter 4002. As seen in FIG.41, the support stent 10 now assumes its relaxed, uncompressed shape butremains connected to the outer fork 4040 and the inner fork 4038 at itsretaining arms 21, 23, 25. In this configuration, the support stent 10can be rotated (in the clockwise or counter-clockwise directions) orrepositioned (in the proximal and distal directions and/or into adifferent position in the x-y plane) into a proper orientation adjacentto its intended target area. For example, the support stent 10 can bepositioned against the upper surfaces of leaflets of the aortic valve inthe manner illustrated in FIG. 2 while the support stent 10 remainsconnected to the delivery system 4000 via the retaining arms 21, 23, 25.

As more fully illustrated below in FIGS. 42-46, a prosthetic valve(e.g., a THV) can be delivered to the aortic valve entirely through atranfemoral approach (e.g., through the aortic arch of the heart) usingthe deployment system 4000. The prosthetic valve 4070 can be deployedtransfemorally such that the prosthetic valve is secured in place byfrictional engagement between the support stent, the native leaflets,and the prosthetic valve. As explained above with reference to FIGS. 4and 5, the support stent 10 can be shaped so that the native leaflets ofthe aortic valve become trapped or pinched between the support stent 10and the exterior of the prosthetic valve 4070 when the prosthetic valveis expanded and deployed within the native valve. The deployment system4000 can be used, for example, to deliver a support stent 10 to treataortic insufficiency, as well as any other condition in which the aortaor aortic valve may not be in condition to help support the prostheticvalve (e.g., when the aortic annulus is too dilated or in which theleaflets of the aorta are too weak or soft to support the prostheticvalve).

FIGS. 42-46 illustrate one exemplary procedure for deploying the supportstent and securing a prosthetic valve (e.g., a THV) to the supportstent. In particular, FIGS. 42-46 are cross-sectional views through theleft side of a patient's heart showing the acts performed in deliveringthe support stent 10 through the aortic arch to the aortic valve. Inorder to better illustrate the components of the delivery system 4000,the main catheter 4002 is shown partially cut away in FIGS. 42-36.

FIG. 42 shows the main catheter 4002 of the delivery system 4000 as itis advanced through the aortic arch 4202 into a position near thesurface of the outflow side of the aortic valve 4210. The deliverysystem 4000 can be inserted through the femoral artery of the patientand advanced into the aorta in the retrograde direction. FIG. 42 alsoshows the outer fork 4040 of the stent delivery outer catheter 4008, theinner fork 4038 of the stent delivery inner catheter 4018, theprosthetic valve delivery catheter 4060, nose cone 4050, and the supportstent 10. In FIG. 42, the main catheter 4002 is advanced in thedirection of guidewire 4080, which is shown as being extended throughthe aortic valve 4210. The delivery system 4000 is advanced to the pointwhere the nose cone 4050 is located adjacent to the native leaflets ofthe aortic valve when the valve is closed. In FIG. 42, the support stent10 is in its radially compressed, predeployment state. Also seen in FIG.42 are the outer fork 4040 and the inner fork 4038, which releasablycouples the radially compressed support stent 10 to the distal ends ofthe stent delivery outer catheter 4008 and the stent delivery innercatheter 4018, respectively. In FIG. 40, the prosthetic valve 4070 isshown as not being enclosed by the main catheter 4002. However, in otherembodiments, the main catheter 4002 can be configured to enclose theprosthetic valve 4070 during insertion of the delivery system 4000 intothe vasculature of the patient.

In FIG. 43, the main catheter 4002 is withdrawn from the stent deliveryouter catheter 4008, the stent delivery inner catheter 4018, and thesupport stent 10. When the main catheter 4002 is withdrawn, the supportstent 10 is no longer held within the inner walls of the main catheterand expands into its uncompressed, natural shape in a position above theaortic valve 4210. In FIG. 43, the support stent 10 is self-expanding.In other embodiments, however, the support stent may not beself-expanding. In such embodiments, the support stent can be made of asuitable ductile material, such as stainless steel. In addition, amechanism for expanding the support stent can be included as part of thedelivery system 4000. For example, and as explained above with respectto FIG. 8, the support stent can be disposed around a balloon of aballoon catheter in a compressed state. At this point in the exemplaryprocedure, portions of the delivery system 4000 are ready to be advancedfurther into the aortic valve, led by the nose cone 4050.

In FIG. 44, the prosthetic valve delivery catheter 4060 is advancedthrough the aortic valve 4210 led by the nose cone 4050. In theillustrated position, the prosthetic valve delivery catheter 4060 isadvanced to a point where the balloon portion 4064 and compressedprosthetic valve 4070 are located on the inflow side of the aortic valve4210. In FIG. 44, the stent delivery outer catheter 4008 and the stentdelivery inner catheter 4018 are also advanced toward the aortic valve4210 but remain on the outflow side of the aortic valve 4210. Inparticular, the stent delivery outer catheter 4008 and the stentdelivery inner catheter 4018 are positioned so that the support stent 10is placed adjacent to or directly on the surface of the outflow side ofthe aortic valve. The support stent 10 is rotated and positioned asnecessary so that the support stent generally circumscribes the aorticvalve and so that the peaks of the support stent are aligned with thetips of the natural leaflets of the aortic valve 4210. Therefore, whenthe prosthetic valve 4070 is inserted and expanded within the aorticvalve 4210, the leaflets of the aortic valve will engage at least themajority of the surface in the interior of the support stent 10. Thisalignment will create an overall tighter fit between the support stent10 and the prosthetic valve. In other embodiments, the support stent 10is rotated and positioned as necessary so that the peaks of the supportstent 10 are aligned with the commissures or other portions of theaortic valve 4210. The position of the main catheter 4002 and thesupport stent 10 relative to the aortic valve 4210, as well as theposition of other elements of the system, can be monitored usingradiopaque markers and fluoroscopy, or using other imaging systems suchas transesophageal echo, transthoracic echo, intravascular ultrasoundimaging (“IVUS”), or an injectable dye that is radiopaque. Additionally,longitudinal alignment of the two implants can be engineered via “hardstops” or locking mechanisms designed into the proximal handle system.

Also seen in FIG. 44 are the prongs of the outer fork 4040 and theprongs of the inner fork 4038. In the exemplary procedure, the prongs ofthe outer fork 4040 and the inner fork 4038 remain secured to thesupport stent 10 until the prosthetic valve is deployed and frictionallyengaged to the support stent. The inner and outer forks desirably form aconnection between the stent 10 and the delivery system 4000 that issecure and rigid enough to allow the clinician to hold the stent 10 atthe desired implanted position against the flow of blood while theprosthetic valve is being implanted. The inner and outer forks are alsodesirably flexible enough to allow for balloon inflation of theprosthetic valve within the fork prong area.

In FIG. 45, the prosthetic valve delivery catheter 4060 is retracted sothat the balloon portion 4064 and the prosthetic valve 4070 are locatedin the aortic annulus and between the native aortic leaflets. Inparticular, the compressed prosthetic valve 4070 is locatedconcentrically within the aortic valve and within the interior of thesupport stent 10. Furthermore, the balloon portion 4064 is expanded toexpand the prosthetic valve 4070, thereby causing the exterior of theprosthetic valve to engage the leaflets of the aortic valve 4210, and inturn cause the leaflets of the aortic valve to engage the interior ofthe support stent 10. In other words, the expansion of the prostheticvalve 4070 pinches the leaflets of the aortic valve 4210 between thesupport stent 10 and the prosthetic valve, thereby securing theprosthetic valve within the annulus of the aortic valve. In order tobetter illustrate the components of the delivery system for theprosthetic valve, FIGS. 44-46 show the front third of the support stent10 and the front of the prosthetic valve 4070, but do not show theportions of the native heart valve that would be secured by the front ofthe support stent 10. It is to be understood, however, that acorresponding leaflet of the native heart valve would be secured betweenthe support stent 10 and the prosthetic valve 4070.

Radiopaque or other imaging markers may be provided on the prostheticvalve delivery catheter 4060 to more accurately determine the positionof the valve 4070 and the balloon portion 4064 relative to the supportstent 10 and the aortic valve 4210. In some embodiments, the cliniciancan adjust the position of the valve 4070 by actuating a steering ordeflecting mechanism within the prosthetic valve delivery catheter 4060.Furthermore, the rotational orientation of the valve 4070 can beadjusted relative to the cusps and commissures of the native aorticvalve by twisting the prosthetic valve delivery catheter 4060 from itsproximal end and observing specific markers on the valve (or prostheticvalve delivery catheter) using fluoroscopy or other imaging technology.

Once the prosthetic valve 4070 is secured into its desired position, theballoon portion 4064 can be deflated so that the prosthetic valvedelivery catheter 4060 becomes disengaged from the expanded prostheticvalve 4070. The prosthetic valve delivery catheter 4060 can then bewithdrawn. The stent delivery inner catheter 4018 of the delivery system4000 can be retracted, thereby causing the prongs of the inner fork 4038to become disengaged from the retaining arms of the support stent 10.Once the prongs of the inner fork 4038 are disengaged, the prongs of theouter fork 4040 can be disengaged from the retaining arms by retractingthe stent delivery outer catheter 4008. Once the support stent 10 andthe prosthetic valve 4070 are disengaged from the delivery system 4000,the stent delivery outer catheter 4018, the stent delivery innercatheter 4018, and the prosthetic valve delivery catheter 4060 can beretracted (at least partially) into the main catheter 4002. The deliverysystem 4000 can then be retracted from the aortic arch 4202 over theguide wire 4080 and removed from the patient. The guide wire can then bewithdrawn from the patient as well, leaving the prosthetic valve 4070securely positioned within the aortic valve 4210 by the support stent 10as shown by FIG. 46.

FIG. 47 is a front view of an embodiment of a delivery system 4700 thatis similar to the embodiment shown in FIG. 40 but in which the innerfork catheter is replaced by one or more cables or wires. In particular,FIG. 47 shows the delivery system when the support stent 10 is in acompressed, predeployed state. The delivery system 4700 comprises a maincatheter 4702 (which can be a steerable guide catheter) having anelongated shaft 4704. The delivery system 4700 also includes a stentdelivery outer catheter 4708 positioned in the interior of the maincatheter 4702. The stent delivery outer catheter 4708 has an elongatedshaft 4710 and an outer fork 4740 connected to a distal end portion ofthe shaft 4710. The shaft 4710 of the stent delivery outer catheter 4708can be configured to be moveable axially relative to the other shafts ofthe delivery system 4700 (e.g., using a handle or lever (such as alockable handle or lever) located at or near a proximal end of thedelivery system 4700 as is known in the art). Furthermore, the shaft4710 of the stent delivery outer catheter 4708 can be sized so that itsexterior wall is adjacent to or in contact with the inner wall of theshaft 4704 of the main catheter 4702.

Instead of a stent delivery inner catheter, the delivery system 4700includes threads or wires 4781, 4783, 4785 having distal ends that forma hook, slip knot, suture loop, or other shape that allows the threadsor wires to be releasably engage the retaining arms 21, 23, 25 of thesupport stent. The wires 4781, 4783, and 4785 can alternatively includea fastening mechanism at their distal end that allows the wires to bereleasably coupled to the retaining arms 21, 23, 25. In general, thewires 4781, 4783, and 4785 operate in substantially the same fashion asthe prongs of the inner fork 4038 shown in FIG. 40. For example, each ofthe wires 4881, 4783, and 4785 can include a suture loop at its distalend that is configured to be threaded through the eyelets (not shown) ofthe retaining arms 21, 23, 25, thereby securing the prongs of the outerfork 4740 to the retaining arms in the fashion shown in FIG. 6. Thewires 4781, 4783, 4785 can extend through the interior of the stentdelivery outer catheter 4708 (e.g., through an annular lumen or one ormore interior lumens of the stent delivery outer catheter 4708) toproximal ends at or near the proximal end of the main catheter 4702. Theproximal ends of the wires 4781, 4783, 4785 can be coupled to a handleor other control mechanism configured to allow for the wires to beretracted relative to the stent delivery outer catheter 4708. Whenretracted, the distal ends of the wires 4781, 4783, 4785 becomedisengaged from the retaining arms 21, 23, 25 (e.g., by releasing aslip-knot or suture loop, by causing a hooked portion of the wires to bestraightened and pulled through the eyelet of a retaining arm, or byanother such releasing mechanism). Once the wires 4781, 4783, 4785 aredisengaged, the prongs of the outer fork 4740 become disengaged, therebyreleasing the support stent in its desired position.

As with the delivery system 4000, the delivery system 4700 furtherincludes a prosthetic valve delivery catheter 4760. The prosthetic valvedelivery catheter 4760 comprises an elongated shaft 4762 positioned inthe interior of the stent delivery inner catheter 4718 and a balloonportion 4764 located near a distal end of the elongated shaft 4762. Theshaft 4762 of the prosthetic valve delivery catheter 4760 can beconfigured to be moveable axially relative to the other shafts of thedelivery system 4700 (e.g., using a handle or lever (such as a lockablehandle or lever) located at or near a proximal end of the deliverysystem 4700 as is known in the art). As with the delivery system 4000, aprosthetic valve 4770 (e.g., a THV) is positioned around the balloonportion 4764 in a crimped or unexpanded state. The delivery system 4700can be used to deliver the prosthetic valve 4770 to its desired locationadjacent to or on the outflow side of the aortic valve in the mannerdescribed above with respect to FIGS. 42-46.

FIGS. 48 and 49 are front views of the distal end portion of anexemplary delivery system 4800 for delivering the support stent 10 toits location adjacent the native aortic valve through a patient's leftventrical (e.g., transapically). In particular, FIG. 48 shows thedelivery system 4800 when the support stent 10 is in a compressed,predeployed state, whereas FIG. 48 shows the delivery system 4800 whenthe support stent 10 is in a decompressed, deployed state. The deliverysystem 4800 comprises an introducer sheath 4802 (which can alternativelybe a steerable guide catheter) having an elongated shaft that is axiallyand rotatably movable relative to the other shafts of the deliverysystem 4800 (e.g., using a handle or lever (such as a lockable handle orlever) located at or near a proximal end of the delivery system 4800 asis known in the art). The introducer sheath 4802 of the illustratedembodiment is further configured to have the same or approximately thesame circumference as an elongated nose cone 4850. The elongated nosecone 4850 includes a tapered distal portion 4854 and a distal end 4851that can include a small lumen through which a guide wire can beinserted and further forms a housing circumferentially surrounding astent delivery outer fork catheter 4808, a stent delivery inner forkcatheter 4818, and a compressed support stent 10. For illustrativepurposes, the nose cone 4850 is shown as being partially cut away, thusrevealing the catheters in its interior.

A proximal end (not shown) of the introducer sheath 4802 is connected toa handle of the delivery system 4800. During delivery of the supportstent, the handle can be used by a clinician to advance and retract thedelivery system through the patient's heart. In a particular use, thedelivery system 4800 is advanced transapically over a guide wire throughthe left ventricle of a patient's heart after having been insertedthrough a puncture in the left ventricle.

The delivery system 4800 includes a prosthetic valve delivery catheter4860. The prosthetic valve delivery catheter 4860 comprises an elongatedshaft 4862 positioned in the interior of the introducer sheath 4802 anda balloon portion 4864 located near a distal end of the elongated shaft4862. The shaft 4862 of the prosthetic valve delivery catheter 4860 canbe configured to be moveable axially relative to the other shafts of thedelivery system 4800 (e.g., using a handle or lever (such as a lockablehandle or lever) located at or near a proximal end of the deliverysystem 4800 as is known in the art). In some embodiments, the shaft 4862is configured to be sized so that its exterior wall is adjacent to or incontact with the inner wall of the shaft 4804 of the introducer sheath4802. In the illustrated embodiment, the shaft 4862 is the outermostcatheter within the introducer sheath 4802. Furthermore, the balloonportion 4864 defines a lumen through which one or more additionalcatheters are placed. A prosthetic valve 4870 (e.g., a THV) ispositioned around the balloon portion 4864 in a crimped or unexpandedstate. The prosthetic valve 4870 can be any suitable expandableprosthetic heart valve, such as those described in U.S. PatentApplication Publication No. 2007/0112422 (U.S. application Ser. No.11/280,063) and 2010/0049313 (U.S. application Ser. No. 12/429,040),which are expressly incorporated herein by reference. The prostheticvalve delivery catheter 4860 can include one or more fluid lumens (notshown) through which a suitable liquid or gas can be inserted to causethe balloon portion to expand, thereby expanding the prosthetic valve4870 into its expanded state (e.g., the prosthetic valve deliverycatheter 4860 can be a balloon catheter). The one or more fluid lumensof the prosthetic valve delivery catheter 4860 can be an annular lumenor a non-concentric (or offset) lumen that allows one or more furtherlumens to be defined within the prosthetic valve delivery catheter 4860.In certain embodiments, the prosthetic valve delivery catheter 4860itself comprises multiple catheters, including an outer catheter towhich the balloon is attached and an inner catheter that is coupled tothe balloon only at the balloon's distal end. With such a design, fluidcan be inserted in the annular space between the outer catheter and theinner catheter. In FIG. 48, the prosthetic valve 4870 is shown as notbeing enclosed by the introducer sheath 4802. However, in otherembodiments, the introducer sheath 4802 can be configured to enclose theprosthetic valve 4870 during insertion of the delivery system 4800 intothe vasculature of the patient.

As noted, the delivery system 4800 also includes a stent delivery outerfork catheter 4808 and a stent delivery inner fork catheter 4818. In theillustrated embodiment, the stent delivery inner fork catheter 4818comprises a stent delivery inner fork 4838 positioned in the interior ofthe elongated nose cone 4850 and secured to a distal end of an elongatedshaft 4820. The shaft 4820 can be sized to fit within the lumen of theprosthetic valve delivery catheter 4860. In particular, the shaft 4820can be configured to be moveable axially relative to the other shafts ofthe delivery system 4800 (e.g., using a handle or lever (such as alockable handle or lever) located at or near a proximal end of thedelivery system 4800 as is known in the art). Furthermore, the shaft4820 can be sized so that its exterior wall is adjacent to or in contactwith the inner wall of the lumen of the prosthetic valve deliverycatheter 4860.

The stent delivery outer fork catheter 4808 comprises a stent deliveryouter fork 4840 positioned in the interior of the nose cone 4850 andsecured to a distal end of an elongated shaft 4810. In this embodiment,the shaft 4810 of the stent delivery outer fork catheter 4808 is sizedto fit within the stent delivery inner fork catheter 4818. Inparticular, the shaft 4810 of the stent delivery outer fork catheter4808 can be configured to be moveable axially relative to the othershafts of the delivery system 4800 (e.g., using a handle or lever (suchas a lockable handle or lever) located at or near a proximal end of thedelivery system 4800 as is known in the art). Furthermore, the shaft4810 of the stent delivery outer catheter 4808 can be sized so that itsexterior wall is adjacent to or in contact with the inner wall of theshaft 4820 of the stent delivery inner fork catheter 4818. (Note thatthis is in contrast to the delivery system 4000 described above in whichthe shaft 4010 of the stent delivery outer catheter 4008 has a largercircumference than the shaft 4020 of the stent delivery inner catheter4018 and encloses the shaft 4020.)

The stent delivery system 4800 further includes a nose cone catheter4852 having a shaft 4856 and a distal end to which the nose cone 4850 issecured. For example, the distal portion 4854 of the nose cone 4850 canbe attached to the distal end of the nose cone catheter 4852. The nosecone 4850 can be attached to the nose cone catheter 4852, for instance,using a suitable adhesive, a frictional engagement mechanism (e.g., asnap-fit or threaded collar attachment), by forming the nose cone 4850and the nose cone catheter 4852 as part of a single unibody element(e.g., using suitable molding techniques), or other such attachmentmechanisms. In the illustrated embodiment, shaft 4856 of the nose conecatheter 4852 can be sized so that its exterior wall is adjacent to orin contact with the inner wall of the shaft 4810 of the stent deliveryouter fork catheter 4818. In particular, the shaft 4856 of the nose conecatheter 4852 can be configured to be moveable axially relative to theother shafts of the delivery system 4800 (e.g., using a handle or lever(such as a lockable handle or lever) located at or near a proximal endof the delivery system 4800 as is known in the art). Additionally, thenose cone catheter 4852 can define an interior lumen through a guidewire can extend. For instance, a guide wire 4880 can be inserted throughthe nose cone catheter 4852 such that it extends through a distal end4851 of the elongated nose cone 4850.

In FIG. 48, the support stent 10 is shown in a radially compressed statein the interior of the elongated nose cone 4850. In this undeployed andcompressed state, the prongs of the outer fork 4840 and the inner fork4838 of the stent delivery outer fork catheter 4808 and the stentdelivery inner fork catheter 4818 engage the retaining arms 21, 23, 25of the support stent 10 in the manner described above with respect toFIGS. 5 and 6. To deploy the support stent 10 in the illustratedembodiment (advance the stent from the delivery system 4800), the nosecone catheter and the elongated nose cone 4850 are advanced distallyrelative to the stent delivery outer fork catheter 4808 and the stentdelivery inner fork catheter 4818 using one or more control handles ormechanisms (not shown) located at the proximal end of the deliverysystem 4800. This action causes the stent 10 to be revealed through aproximal end 4858 of the elongated nose cone 4850. When the wall of theelongated nose cone 4850 extends beyond the support stent 10, thesupport stent can expand into its relaxed, uncompressed state (shown,for example, in FIGS. 1 and 2).

FIG. 49 is a front view showing the support stent 10 after the nose cone4850 has been advanced to reveal the support stent to the exterior ofthe delivery system 4800. As seen in FIG. 49, the support stent 10 nowassumes its relaxed, uncompressed shape but remains connected to theouter fork 4840 and the inner fork 4838 at its retaining arms 21, 23,25. In this configuration, the support stent 10 can be rotated (in theclockwise or counter-clockwise directions) or repositioned (in theproximal and distal directions and/or into a different position in thex-y plane) into a proper orientation adjacent to its intended targetarea. For example, the support stent 10 can be positioned against theupper surfaces of leaflets of an aortic valve in the manner illustratedin FIG. 2 while the support stent 10 remains connected to the deliverysystem 4800 via the retaining arms 21, 23, 25.

As more fully illustrated below in FIGS. 50-55, a prosthetic valve(e.g., a THV) can be delivered to the aortic valve entirely through atransapical approach (e.g., through the apex of the heart through theleft ventricle) using the delivery system 4800. The prosthetic valve4870 can be deployed transapically within the native valve such that theprosthetic valve is secured in place by frictional or mechanicalengagement between the support stent 10, the native leaflets, and theprosthetic valve. As explained above with reference to FIGS. 4 and 5,the support stent 10 can be shaped so that the native leaflets of theaortic valve become trapped or pinched between the support stent 10 andthe exterior of the prosthetic valve 4870 when the prosthetic valve isexpanded and deployed within the native valve. The deployment system4800 can be used, for example, to deliver a support stent 10 to treataortic insufficiency, as well as any other condition in which the aortaor aortic valve may not be in condition to help support the prostheticvalve (e.g., when the aortic annulus is too dilated or in which theleaflets of the aorta are too weak or soft to support the prostheticvalve).

FIGS. 50-55 illustrate one exemplary procedure for deploying the supportstent and securing the prosthetic valve 4870 (e.g., a THV) to thesupport stent 10 using the delivery system 4800 or other suchtransapical delivery system. In particular, FIGS. 50-55 arecross-sectional views through the left side of a patient's heart showingthe acts performed in delivering the support stent 10 through the leftventricle and into the annulus of the aortic valve. In order to betterillustrate the components of the delivery system 4800, the introducersheath 4802 is shown partially cut away in FIGS. 50-55.

FIG. 50 shows the introducer sheath 4802 and the nose cone 4850 of thedelivery system 4800 as they are advanced toward the aortic valve 5010.FIG. 50 also shows the outer fork 4840 of the stent delivery outer forkcatheter 4808, the inner fork 4838 of the stent delivery inner forkcatheter 4818, the prosthetic valve delivery catheter 4860, and thesupport stent 10. In FIG. 50, the introducer sheath 4802 is advanced inthe direction of guidewire 4880, which is shown as being extendedthrough the aortic valve 5010. In FIG. 50, the prosthetic valve 4870 isshown as not being enclosed by the introducer sheath 4802. However, inother embodiments, the introducer sheath 4802 can be configured toenclose the prosthetic valve 4870 during insertion of the deliverysystem 4800 into the vasculature of the patient.

In FIG. 51, the introducer sheath 4802 and the nose cone 4850 areadvanced over the guidewire 4880 through the annulus of the aortic valve5010. In particular, the nose cone 4850 is advanced so that the supportstent 10 is located in a position that is above the native leaflets ofthe aortic valve when the valve is open.

Also seen in FIG. 51 is the valve delivery catheter 4870, which ispositioned adjacent or near to the inflow side of the aortic valve 5010.This positioning allows the operator of the delivery system 4800 toposition the support stent 10 into its proper location without anyinterference in the aortic valve 5010 caused by the presence of theprosthetic valve 4870 in the interior of the native valve.

In FIG. 52, the nose cone 4850 is advanced distally relative to theouter fork 4840 of the stent delivery outer fork catheter 4808 (notvisible in FIG. 52) and the inner fork 4838 of the stent delivery innerfork catheter 4818. With the nose cone 4850 advanced, the support stent10 is no longer held within the inner walls of the nose cone 4850 andexpands into its uncompressed, natural shape in a position on theoutflow side of the aortic valve 5010. In FIG. 51, the support stent 10is self-expanding. In other embodiments, however, the support stent maynot be self-expanding. In such embodiments, the support stent can bemade of a suitable ductile material, such as stainless steel. Inaddition, a mechanism for expanding the support stent can be included aspart of the delivery system 4800. For example, and as explained abovewith respect to FIG. 8, the support stent can be disposed around aballoon of a balloon catheter in a compressed state

In FIG. 52, the stent delivery outer fork catheter 4808 (not visible inFIG. 52) and the stent delivery inner fork catheter 4818 are positionedso that the support stent 10 is placed adjacent to or directly on thesurface of the outflow side of the aortic valve. The support stent 10 isrotated and positioned as necessary so that the support stent generallycircumscribes the aortic valve and so that the peaks of the supportstent are aligned with the tips of the natural leaflets of the aorticvalve 5010. Therefore, when the prosthetic valve 4870 is inserted andexpanded within the aortic valve 5010, the leaflets of the aortic valvewill engage at least the majority of the surface in the interior of thesupport stent 10. In other embodiments, the support stent 10 is rotatedand positioned as necessary so that the peaks of the support stent arealigned with the commissures or other portions of the aortic valve. Theposition of the introducer sheath 4802, the nose cone 4850, theprosthetic valve 4870, and the support stent 10 relative to the aorticvalve 5010, as well as the position of other elements of the system, canbe monitored using radiopaque markers and fluoroscopy, or using otherimaging systems such as transesophageal echo, transthoracic echo,intravascular ultrasound imaging (“IVUS”), or an injectable dye that isradiopaque.

Also seen in FIG. 52 are the prongs of the outer fork 4840 and theprongs of the inner fork 4838. In the exemplary procedure, the prongs ofthe outer fork 4840 and the inner fork 4838 remain secured to thesupport stent 10 until the prosthetic valve is deployed and frictionallyengaged to the support stent. The inner and outer forks 4838, 4840desirably form a connection between the stent 10 and the delivery systemthat is secure and rigid enough to allow the clinician to hold the stent10 at the desired implanted position against the flow of blood while theprosthetic valve is being implanted.

Also seen in FIG. 52 is the valve delivery catheter 4860, which ispositioned adjacent or near to the inflow side of the aortic valve 5010.This positioning allows the operator of the delivery system 4800 toposition the support stent 10 into its proper location without anyinterference in the aortic valve 5010 caused by the presence of theprosthetic valve 4870 in the interior of the native valve.

In FIG. 53, the support stent 10 is properly positioned and oriented onthe outflow side of the aortic valve 5010. The valve delivery catheter4860 is then advanced into the aortic valve 5010 so that the prostheticvalve 4870 is located within the interior of the annulus of the aorticvalve and within the interior of the expanded support stent 10 (e.g.,concentrically with the annulus of the aortic valve and the expandedsupport stent 10).

At the point in the exemplary procedure illustrated in FIG. 53, thecompressed prosthetic vlave 4870 is ready to be expanded into the aorticvalve 5010. The balloon portion 4864 is then inflated to expand theprosthetic valve 4870, thereby causing the exterior of the prostheticvalve to engage the leaflets of the aortic valve 5010, and in turn causethe leaflets of the aortic valve to engage the inner wall of the supportstent 10. In other words, the expansion of the prosthetic valve 4870pinches the leaflets of the aortic valve 5010 between the support stentand the prosthetic valve 4870, thereby securing the prosthetic valvewithin the annulus of the aortic valve.

In order to better illustrate the components of the delivery system forthe prosthetic valve, FIGS. 52 through 55 show the front third of thesupport stent 10 and the front of the prosthetic valve 4870, but do notshow the portions of the native heart valve that would be secured by thefront of the support stent 10. It is to be understood, however, that acorresponding leaflet of the native heart valve would be secured betweenthe support stent 10 and the prosthetic valve 4870.

Radiopaque markers may be provided on the prosthetic valve deliverycatheter 4860 to more accurately determine the position of the valve4870 and the balloon portion 4864 relative to the support stent 10 andthe aortic valve 5010. In some embodiments, the clinician can adjust theposition of the valve 4870 by actuating a steering or deflectingmechanism within the prosthetic valve delivery catheter 4860.Furthermore, the rotational orientation of the valve 4870 can beadjusted relative to the cusps and commissures of the native aorticvalve by twisting the prosthetic valve delivery catheter 4860 from itsproximal end and observing specific markers on the valve (or prostheticvalve delivery catheter) under fluoroscopy.

As shown in FIG. 54, once the prosthetic valve 4870 is secured into itsdesired position, the balloon portion 4864 can be deflated and the stentdelivery inner fork catheter 4818 of the delivery system 4800 can beadvanced distally while the stent delivery outer fork catheter 4808 isheld in a constant position, thereby causing the prongs of the innerfork 4838 to become disengaged from the retaining arms of the supportstent 10. Once the prongs of the inner fork 4838 are disengaged, theprongs of the outer fork 4840 become disengaged from the retaining arms.The stent delivery outer fork catheter 4808 is then advanced distally.Furthermore, and as also illustrated in FIG. 54, the stent deliveryinner fork catheter 4818 and the stent delivery outer fork catheter 4808can be advanced into the elongated nose cone 4850 so that the prongs ofthe inner fork 4838 and the prongs of the outer fork 4840 are enclosedwithin the walls of the nose cone. With the balloon portion 4864deflated and the stent delivery inner fork catheter 4818 and the stentdelivery outer fork catheter 4808 (as well as the prongs of theirassociated forks) being enclosed by the nose cone, the nose cone 4850and the prosthetic valve delivery catheter 4860 can be retracted intothe introducer sheath 4802. The delivery system 4800 can then beretracted from the left ventricle over the guide wire and removed fromthe patient, leaving the prosthetic valve 4870 securely positionedwithin the aortic valve 5010 by the support stent 10 as shown in FIG.55.

It should be noted that the balloon-expandable prosthetic valve used inthe above embodiments can take a variety of different forms and maycomprise an expandable stent portion that supports a valve structure.The stent portion desirably has sufficient radial strength to hold thevalve at the treatment site and to securely engage the support stent 10.Additional details regarding balloon expandable valve embodiments thatcan be used in connection with the disclosed technology are described inU.S. Pat. Nos. 6,730,118 and 6,893,460, both of which are herebyexpressly incorporated herein by reference.

FIG. 56 is a front view of the distal end portion of an exemplarydelivery system 5600 for delivering the support stent 10 to its locationadjacent the native aortic valve through a patient's vasculature (e.g.,transfemorally). In contrast to the embodiment illustrated in FIGS. 40and 41, the prosthetic valve used with the delivery system 5600 is aself-expanding prosthetic valve 5670. FIG. 56 shows the delivery system5600 when the support stent 10 is in a compressed, predeployed state.The delivery system 5600 comprises a main catheter 5602 having anelongated shaft 5604, whose distal end 5605 is open and is configured tohave a diameter that is the same as or approximately the same as nosecone 5650. In other embodiments, the distal end 5605 of the maincatheter 5602 can be tapered (e.g., tapered into a conical shapecomprising multiple “flaps” forming a protective nose cone that can beurged apart when the support stent 10 and any interior catheters areadvanced therethrough or into any other tapered profile, such as thoseidentified above with respect to the embodiment shown in FIGS. 40 and41). Furthermore, for illustrative purposes, the main catheter 5602 isshown as being partially cut away, thus revealing the catheters in itsinterior.

A proximal end (not shown) of the main catheter 5602 is connected to ahandle of the delivery system 5600. During delivery of a support stent,the handle can be used by a clinician to advance and retract thedelivery system through the patient's vasculature. In a particular use,the delivery system 5600 is advanced through the aortic arch of apatient's heart in the retrograde direction after having beenpercutaneously inserted through the femoral artery. The main cathetercan be configured to be selectively steerable or bendable to facilitateadvancement of the delivery system 5600 through the patient'svasculature. An exemplary steerable catheter as can be used inembodiments of the disclosed technology is described in detail in U.S.Patent Application Publication No. 2007/0005131 (U.S. patent applicationSer. No. 11/152,288), which is hereby expressly incorporated herein byreference.

The delivery system 5600 also includes a stent delivery outer catheter5608 positioned in the interior of the main catheter 5602. The stentdelivery outer catheter 5608 has an elongated shaft 5610 and an outerfork 5640 connected to a distal end portion of the shaft 5610. The shaft5610 of the stent delivery outer catheter 5608 can be configured to bemoveable axially relative to the other shafts of the delivery system5600 (e.g., using a handle or lever (such as a lockable handle or lever)located at or near a proximal end of the delivery system 5600 as isknown in the art). Furthermore, the shaft 5610 of the stent deliveryouter catheter 5608 can be sized so that its exterior wall is adjacentto or in contact with the inner wall of the shaft 5604 of the maincatheter 5602.

The delivery system 5600 also includes a stent delivery inner catheter5618 positioned in the interior of the stent deliver outer catheter5608. The stent delivery inner catheter 5618 can have an elongated shaft(not shown) and an inner fork 5638 secured to the distal end portion ofthe shaft. The shaft of the inner catheter 5618 can be configured to bemoveable axially relative to the other shafts of the delivery system5600 (e.g., using a handle or lever (such as a lockable handle or lever)located at or near a proximal end of the delivery system 5600 as isknown in the art). Furthermore, the shaft of the inner catheter 5618 canbe sized so that its exterior wall is adjacent to or in contact with theinner wall of the shaft 5610 of the stent delivery outer catheter 5608.

The delivery system 5600 further includes a prosthetic valve sheath 5690positioned in the interior of the stent delivery inner catheter 5618.The prosthetic valve sheath 5690 encloses a prosthetic valve deliveryouter catheter 5660, a prosthetic valve delivery inner catheter 5665,and a compressed prosthetic valve 5670. The prosthetic valve sheath 5690comprises an elongated shaft 5692 that terminates in an open distal end.The shaft 5692 of the prosthetic valve sheath 5690 can be configured tobe moveable axially relative to the other shafts in the delivery system5600 (e.g., using a handle or lever (such as a lockable handle or lever)located at or near a proximal end of the delivery system 5600 as isknown in the art). Furthermore, the shaft 5692 can be sized so that itsexterior wall is adjacent to or in contact with the inner wall of theshaft 5620 of the stent delivery inner catheter 5618.

The prosthetic valve delivery outer catheter 5660 has an elongated shaft5662 and an outer fork 5664 connected to a distal end portion of theshaft 5662. The shaft 5662 of the prosthetic valve delivery outercatheter 5660 can be configured to be moveable axially relative to theother shafts of the delivery system 5600 (e.g., using a handle or lever(such as a lockable handle or lever) located at or near a proximal endof the delivery system 5600 as is known in the art). Furthermore, theshaft 5662 of the prosthetic valve delivery outer catheter 5660 can besized so that its exterior wall is adjacent to or in contact with theinner wall of the shaft 5692 of the prosthetic valve sheath 5690.

The prosthetic valve delivery inner catheter 5665 can have an elongatedshaft 5666 and an inner fork 5668 secured to the distal end portion ofthe shaft 5666. The shaft 5666 of the inner catheter 5665 can beconfigured to be moveable axially relative to the other shafts of thedelivery system 5600 (e.g., using a handle or lever (such as a lockablehandle or lever) located at or near a proximal end of the deliverysystem 5600 as is known in the art).

In the illustrated embodiment, a nose cone catheter 5658 is locatedwithin the prosthetic valve delivery inner catheter 5665 and has adistal end that is attached to a nose cone 5650. In other embodiments,the nose cone 5650 is absent. The nose cone catheter 5658 can define aguide wire lumen through which a guide wire 5680 can be inserted. Theguide wire 5680 can extend through a distal end of the nose cone 5650and can be used, for example, to help ensure proper advancement of themain catheter 5602 and its interior catheters through the vasculature ofa patient.

A prosthetic valve 5670 (e.g., a THV) is in a compressed or unexpandedstate and is contained within the prosthetic valve sheath 5690. Theprosthetic valve 5670 can be any suitable expandable prosthetic heartvalve, such as those described in U.S. Patent Application PublicationNos. 2007/0112422 (U.S. application Ser. No. 11/280,063) and2010/0049313 (U.S. application Ser. No. 12/429,040), which are expresslyincorporated herein by reference. Furthermore, in the embodimentillustrated in FIG. 56, the prosthetic valve includes retaining arms5671, 5673, and 5675, which are engaged with the prongs of the outerfork 5664 and the inner fork 5668 of the prosthetic valve delivery outercatheter 5660 and the prosthetic valve delivery inner catheter 5665 inthe manner described above with respect to FIGS. 5 and 6 and asdescribed in U.S. Patent Application Publication No. 2010/0049313 (U.S.application Ser. No. 12/429,040), which is expressly incorporated hereinby reference. To deploy the prosthetic valve 5670 in the illustratedembodiment (advance the valve from the delivery system), the prostheticvalve sheath 5690 together with the prosthetic valve delivery outercatheter 5660 and the prosthetic valve inner catheter 5665 are advancedthrough the distal end 5605 of the main catheter 5602, and then theprosthetic valve sheath 5690 is withdrawn to reveal the valve 5670.These actions can be performed, for example, using one or more controlhandles or mechanisms (not shown) located at the proximal end of themain catheter 5602. These actions cause the prosthetic valve 5670 to beadvanced outwardly through the distal end 5695 of the prosthetic valvesheath 5690 and to expand into its relaxed, uncompressed state. In theillustrated embodiment, the prosthetic valve 5670 is shown as beingpositioned concentrically with the support stent 10. In otherembodiments, however, the support stent 10 can be positioned distally ofthe prosthetic valve 5670.

In FIG. 56, the support stent 10 is shown in a radially compressed statein the interior of the elongated shaft 5604 of the main catheter 5602.In the radially compressed state, the distance along the z axis betweena peak and an adjacent valley of the support stent is greater than thedistance along the z axis between the peak and the adjacent valley whenthe support stent is in it uncompressed state. The distal end portion ofthe shaft 5604 can also be referred to as a delivery sheath for thestent 10. In this undeployed and compressed state, the prongs of theouter fork 5640 and the inner fork 5638 of the stent delivery outercatheter 5608 and the stent delivery inner catheter 5618 engage theretaining arms 21, 23, 25 of the support stent 10 in the mannerdescribed above with respect to FIGS. 5 and 6. To deploy the supportstent 10 in the illustrated embodiment, the main catheter 5602 iswithdrawn over the stent delivery outer catheter 5608 and the stentdelivery inner catheter 5618, thereby advancing the stent delivery outercatheter 5608 and the stent delivery inner catheter 5618 through thedistal end 5605 of the main catheter 5602. This action can be performed,for example, using one or more control handles or mechanisms (not shown)located at the proximal end of the main catheter 5602. Once advancedthrough the main catheter 5602, the support stent 10 can expand into itsrelaxed, uncompressed state (shown, for example, in FIGS. 1 and 2).

As more fully illustrated below in FIGS. 57-61, a prosthetic valve(e.g., a THV) can be delivered to the aortic valve entirely through atranfemoral approach (e.g., through the aortic arch of the heart) usingthe deployment system 5600. The prosthetic valve 5670 can be deployedtransfemorally within the native valve such that the prosthetic valve issecured in place by frictional engagement between the support stent, thenative leaflets, and the prosthetic valve. As explained above withreference to FIGS. 4 and 5, the support stent 10 can be shaped so thatthe native leaflets of the aortic valve become trapped or pinchedbetween the support stent 10 and the exterior of the prosthetic valve5670 when the prosthetic valve is expanded and deployed within thenative valve. The deployment system 5600 can be used, for example, todeliver a support stent 10 to treat aortic insufficiency, as well as anyother condition in which the aorta or aortic valve may not be incondition to help support the prosthetic valve (e.g., when the aorticannulus is too dilated or in which the leaflets of the aorta are tooweak or soft to support the prosthetic valve).

FIGS. 57-61 illustrate one exemplary procedure for deploying the supportstent and securing a prosthetic valve (e.g., a THV) to the supportstent. In particular, FIGS. 57-61 are cross-sectional views through theleft side of a patient's heart showing the acts performed in deliveringthe support stent 10 through the aortic arch to the aortic valve. Inorder to better illustrate the components of the delivery system 5600,the main catheter 5602 is shown partially cut away in FIGS. 57-61.

FIG. 57 shows the main catheter 5602 of the delivery system 5600 as itis advanced through the aortic arch 5702 into a position near thesurface of the outflow side of the aortic valve 5710. The deliverysystem 5600 can be inserted through the femoral artery of the patientand advanced into the aorta in the retrograde direction. In FIG. 57, themain catheter 5602 is advanced in the direction of guidewire 5680, whichis shown as being extended through the aortic valve 5710. The deliverysystem 5600 is advanced to the point where the nose cone 5650 is locatedadjacent to the native leaflets of the aortic valve when the valve isclosed. In FIG. 57, the support stent 10 is in its radially compressed,predeployment state. Also seen in FIG. 57 are the outer fork 5640 of thestent delivery out catheter 5608 and the inner fork 5638 of the stentdelivery inner catheter 5618, which respectively couple the radiallycompressed support stent 10 to the distal ends of the stent deliveryouter catheter 5608 and the stent delivery inner catheter 5618 (notvisible in FIG. 57). FIG. 57 also shows the outer fork 5664 of theprosthetic valve delivery outer catheter 5660 and the inner fork 5668 ofthe prosthetic valve delivery inner catheter 5665, which respectivelycouple the radially compressed prosthetic valve 5670 to the distal endsof the prosthetic valve delivery outer catheter 5660 and the prostheticvalve delivery inner catheter 5665 (not visible in FIG. 56).

In FIG. 58, the main catheter 5602 is withdrawn from the stent deliveryouter catheter 5608, the stent delivery inner catheter 5618, and thesupport stent 10. When the main catheter 5602 is withdrawn, the supportstent 10 is no longer held within the inner walls of the main catheterand expands into its uncompressed, natural shape in a position above theaortic valve 5710. In FIG. 58, the support stent 10 is self-expanding.In other embodiments, however, the support stent may not beself-expanding. In such embodiments, the support stent can be made of asuitable ductile material, such as stainless steel. In addition, amechanism for expanding the support stent can be included as part of thedelivery system 5700. For example, and as explained above with respectto FIG. 8, the support stent can be disposed around a balloon of aballoon catheter in a compressed state.

In FIG. 58, the stent delivery outer catheter 5608 and the stentdelivery inner catheter 5618 are also advanced toward the aortic valve5710 but remain on the outflow side of the aortic valve 5710. Inparticular, the stent delivery outer catheter 5608 and the stentdelivery inner catheter 5618 are positioned so that the support stent 10is placed adjacent to or directly on the surface of the outflow side ofthe aortic valve. The support stent 10 is rotated and positioned asnecessary so that the support stent 10 generally circumscribes theaortic valve and so that the peaks of the support stent are aligned withthe tips of the natural leaflets of the aortic valve 5710. Therefore,when the prosthetic valve 5670 is expanded within the aortic valve 5710,the leaflets of the aortic valve will engage at least the majority ofthe surface in the interior of the support stent 10. This alignment willcreate an overall tighter fit between the support stent 10 and theprosthetic valve. In other embodiments, the support stent 10 is rotatedand positioned as necessary so that the peaks of the support stent 10are aligned with the commissures or other portions of the aortic valve.The position of the main catheter 5602 and the support stent 10 relativeto the aortic valve 5710, as well as the position of other elements ofthe system, can be monitored using radiopaque markers and fluoroscopy,or using other imaging systems such as transesophageal echo,transthoracic echo, intravascular ultrasound imaging (“IVUS”), or aninjectable dye that is radiopaque.

Also seen in FIG. 58 are the prongs of the outer fork 5640 and theprongs of the inner fork 5638. In the exemplary procedure, the prongs ofthe outer fork 5640 and the inner fork 5638 remain secured to thesupport stent 10 until the prosthetic valve 5670 is deployed andfrictionally engaged to the support stent 10. The inner and outer forksdesirably form a connection between the stent 10 and the delivery system5600 that is secure and rigid enough to allow the clinician to hold thestent 10 at the desired implanted position against the flow of bloodwhile the prosthetic valve 5670 is being implanted.

In FIG. 58, the prosthetic valve sheath 5690 (along with its interiorcatheters) is advanced through the aortic valve 5710 led by the nosecone 5650. In the illustrated position, the prosthetic valve sheath 5690is advanced to a point where the compressed prosthetic valve 5670 islocated in the aortic annulus and between the native aortic leaflets. Inparticular, the compressed prosthetic valve 5670 is locatedconcentrically within the aortic valve 5710 and within the interior ofthe support stent 10. Radiopaque markers may be provided on theprosthetic valve sheath 5690, the prosthetic valve delivery outercatheter 5660, and/or the prosthetic valve delivery inner catheter 5665to more accurately determine the position of the valve 5670 relative tothe support stent 10 and the aortic valve 5710. In some embodiments, theclinician can adjust the position of the valve 5670 by actuating asteering or deflecting mechanism within the prosthetic valve sheath5660, the prosthetic valve delivery outer catheter 5660, and/or theprosthetic valve delivery inner catheter 5665. Furthermore, therotational orientation of the valve 5670 can be adjusted relative to thecusps and commissures of the native aortic valve by twisting theprosthetic valve sheath 5690, the prosthetic valve delivery outercatheter 5660, and/or the prosthetic valve delivery inner catheter 5665from their proximal end and observing specific markers on the valve (orany of the catheters) under fluoroscopy. In order to better illustratethe components of the delivery system for the prosthetic valve, FIGS.58-61 show the front third of the support stent 10 and the front of theprosthetic valve 5670, but do not show the portions of the native heartvalve that would be secured by the front of the support stent 10. It isto be understood, however, that a corresponding leaflet of the nativeheart valve would be secured between the support stent 10 and theprosthetic valve 5670.

In FIG. 59, the prosthetic valve sheath 5690 is retracted such that theself-expandable prosthetic valve expands to engage the leaflets of theaortic valve 5710. Consequently, the leaflets of the aortic valve areurged against the inner wall of the support stent 10. In other words,the expansion of the prosthetic valve 5670 pinches the leaflets of theaortic valve 5710 between the support stent 10 and the prosthetic valve5670, thereby securing the prosthetic valve 5670 within the annulus ofthe aortic valve.

Also seen in FIG. 59 are the prongs of the outer fork 5664 of theprosthetic valve delivery outer catheter 5660 and the prongs of theinner fork 5668 of the prosthetic valve delivery inner catheter 5665.The inner and outer forks desirably form a connection between theprosthetic valve 5670 and the delivery system 5600 that is secure andrigid enough to allow the clinician to properly orient the valve 5670into its desired implanted position against the flow of blood throughthe aortic valve 5710.

As shown in FIG. 60, once the prosthetic valve 5670 is secured into itsdesired position, the prosthetic valve delivery inner catheter 5665 ofthe delivery system 5600 can be retracted, thereby causing the prongs ofthe inner fork 5668 to become disengaged from the retaining arms of theprosthetic valve 5670. Once the prongs of the inner fork 5668 aredisengaged, the prongs of the outer fork 5664 become disengaged from theretaining arms, and the prosthetic valve delivery outer catheter 5660can be retracted.

With the prosthetic valve 5670 now disengaged, the stent delivery innercatheter 5618 of the delivery system 5600 can be retracted, therebycausing the prongs of the inner fork 5638 to become disengaged from theretaining arms of the support stent 10. Once the prongs of the innerfork 5638 are disengaged, the prongs of the outer fork 5640 becomedisengaged from the retaining arms, and the stent delivery outercatheter 5608 can be disengaged. In other embodiments, the support stent10 is disengaged from the delivery system 5600 first, or the supportstent 10 and the prosthetic valve 5670 are disengaged at least partiallysimultaneously.

Once the support stent 10 and the prosthetic valve 5670 are disengagedfrom the delivery system 5600, the stent delivery outer catheter 5608,the stent delivery inner catheter 5618, the prosthetic valve sheath5690, the prosthetic valve outer catheter 5660, and the prosthetic valveinner catheter 5665 can all be retracted into the main catheter 5602.The nose cone 5650 can also be retracted through the prosthetic valve5670, and the delivery system 5600 can be retracted from the aortic arch5702 over the guide wire 5680 and removed from the patient. The guidewire 5680 can then be withdrawn from the patient as well, leaving theprosthetic valve 5670 securely positioned within the aortic valve 5710by the support stent 10 as shown by FIG. 61.

FIG. 62 is a front view of an embodiment of a delivery system 6200 thatis similar to the embodiment shown in FIG. 56 but in which one or moreof the stent delivery inner fork catheter and the prosthetic valvedelivery inner catheter are replaced by one or more cables or wires. Inparticular, FIG. 62 shows the delivery system 6200 when the supportstent 10 is in a compressed, predeployed state. The delivery system 6200comprises a main catheter 6202 (which can be a steerable guide catheter)having an elongated shaft 6204 that is axially and rotatably movablerelative to the other shafts of the delivery system 6200 (e.g., using ahandle or lever (such as a lockable handle or lever) located at or neara proximal end of the delivery system 6200 as is known in the art). Thedelivery system 6200 further includes a nose cone 6250.

The delivery system 6200 also includes a stent delivery outer catheter6208 positioned in the interior of the main catheter 6202. The stentdelivery outer catheter 6208 has an elongated shaft 6210 and an outerfork 6240 connected to a distal end portion of the shaft 6210. The shaft6210 of the stent delivery outer catheter 6208 can be configured to bemoveable axially relative to the other shafts of the delivery system6200 (e.g., using a handle or lever (such as a lockable handle or lever)located at or near a proximal end of the delivery system 6200 as isknown in the art). Furthermore, the shaft 6210 of the stent deliveryouter catheter 6208 can be sized so that its exterior wall is adjacentto or in contact with the inner wall of the shaft 6204 of the maincatheter 6202.

Instead of a stent delivery inner catheter, the delivery system 6200includes threads or wires 6281, 6282, 6283 having distal ends that forma hook, slip knot, suture loop, or other shape that allows the threadsor wires to be releasably engage the retaining arms 21, 23, 25 of thesupport stent. The wires 6281, 6282, 6283 can alternatively include afastening mechanism at their distal end that allows the wires to bereleasably coupled to the retaining arms 21, 23, 25. In general, thewires 6281, 6282, 6283 operate in substantially the same fashion as theprongs of the inner fork 5668 of the stent delivery inner catheter 5665shown in FIG. 56. For example, each of the wires 6281, 6282, 6283 caninclude a suture loop at its distal end that is configured to bethreaded through the eyelets (not shown) of the retaining arms 21, 23,25, thereby securing the prongs of the outer fork 6240 of the stentdelivery outer catheter 6208 to the retaining arms in the fashion shownin FIG. 6. The wires 6281, 6282, 6283 can extend through the interior ofthe stent delivery outer catheter 6208 (e.g., through an annular lumenor one or more interior lumens of the stent delivery outer catheter6208) to proximal ends at or near the proximal end of the main catheter6202. The proximal ends of the wires 6281, 6282, 6283 can be coupled toa handle or other control mechanism configured to allow for the wires tobe retracted relative to the stent delivery outer catheter 6208. Whenretracted, the distal ends of the wires 6281, 6282, 6283 becomedisengaged from the retaining arms 21, 23, 25 (e.g., by releasing aslip-knot or suture loop, by causing a hooked portion of the wires to bestraightened and pulled through the eyelet of a retaining arm, or byanother such releasing mechanism). Once the wires 6281, 6282, 6283 aredisengaged, the prongs of the outer fork 6240 of the stent deliveryouter catheter 6208 become disengaged, thereby releasing the supportstent in its desired position.

The delivery system 6200 further includes a prosthetic valve sheath 6290(which can alternatively be a steerable guide catheter) positioned inthe interior of the stent delivery outer catheter 6208. The prostheticvalve sheath 6290 encloses a prosthetic valve delivery outer catheter6260 and a compressed prosthetic valve 6270. The prosthetic valve sheath6290 comprises an elongated shaft 6292 that terminates in an open distalend. The shaft 6292 of the prosthetic valve sheath 6290 can beconfigured to be moveable axially relative to the other shafts in thedelivery system 6200 (e.g., using a handle or lever (such as a lockablehandle or lever) located at or near a proximal end of the deliverysystem 6200 as is known in the art).

The prosthetic valve delivery outer catheter 6260 has an elongated shaft6262 and an outer fork 6264 connected to a distal end portion of theshaft 6262. The shaft 6262 of the prosthetic valve delivery outercatheter 6260 can be configured to be moveable axially relative to theother shafts of the delivery system 6200 (e.g., using a handle or lever(such as a lockable handle or lever) located at or near a proximal endof the delivery system 6200 as is known in the art). Furthermore, theshaft 6262 of the prosthetic valve delivery outer catheter 6260 can besized so that its exterior wall is adjacent to or in contact with theinner wall of the shaft 6292 of the prosthetic valve sheath 6290.

Instead of a prosthetic valve delivery inner catheter, the deliverysystem 6200 includes threads or wires 6284, 6285, 6286 having distalends that form a hook, slip knot, suture loop, or other shape thatallows the threads or wires to be releasably engage the retaining arms6271, 6273, 6275 of the prosthetic valve 6270. The wires 6284, 6285,6286 can alternatively include a fastening mechanism at their distal endthat allows the wires to be releasably coupled to the retaining arms 21,23, 25. In general, the wires 6284, 6285, 6286 operate in substantiallythe same fashion as the prongs of the inner fork 5668 of the prostheticvalve delivery inner catheter 5665 shown in FIG. 56. For example, eachof the wires 6284, 6285, 6286 can include a suture loop at its distalend that is configured to be threaded through the eyelets (not shown) ofthe retaining arms 6271, 6273, 6275, thereby securing the prongs of theouter fork 6264 of the prosthetic valve delivery outer catheter 6260 tothe retaining arms in the fashion shown in FIG. 6. The wires 6284, 6285,6286 can extend through the interior of the prosthetic valve deliveryouter catheter 6260 (e.g., through an annular lumen or one or moreinterior lumens of the prosthetic valve delivery outer catheter 6260) toproximal ends at or near the proximal end of the main catheter 6202. Theproximal ends of the wires 6284, 6285, 6286 can be coupled to a handleor other control mechanism configured to allow for the wires to beretracted relative to the prosthetic valve delivery outer catheter 6260.When retracted, the distal ends of the wires 6284, 6285, 6286 becomedisengaged from the retaining arms 6271, 6273, 6275. Once the wires6284, 6285, 6286 are disengaged, the prongs of the outer fork 6264 ofthe prosthetic valve delivery outer catheter 6260 become disengaged,thereby releasing the prosthetic valve in its desired position.

As with the delivery system 5600, a prosthetic valve 6270 (e.g., a THV)is in a compressed or unexpanded state and is contained within theprosthetic valve sheath 6290. The delivery system 6200 can be used todeliver the prosthetic valve 6270 to its desired location adjacent to oron the outflow side of the aortic valve in the manner described abovewith respect to FIGS. 57-61.

FIG. 63 is a front view of the distal end portion of an exemplarydelivery system 6300 for delivering the support stent 10 to its locationadjacent the native aortic valve through a patient's left ventrical(e.g., transapically). In contrast to the embodiment illustrated inFIGS. 48 and 49, the prosthetic valve used with the delivery system 6300is a self-expanding prosthetic valve 6370. FIG. 63 shows the deliverysystem 6300 when the support stent 10 is in a compressed, predeployedstate. The delivery system 6300 comprises an introducer sheath 6302having an elongated shaft 6304. The introducer sheath 6302 of theillustrated embodiment is configured to have the same or approximatelythe same circumference as a nose cone 6350. The nose cone 6350 can alsobe an elongated nose cone as in the embodiments illustrated in FIGS.48-55. For illustrative purposes, the nose cone 6350 and the introducersheath 6302 are shown as being partially cut away, thus revealing thecatheters in its interior.

A proximal end (not shown) of the introducer sheath 6302 is connected toa handle of the delivery system 6300. During delivery of a supportstent, the handle can be used by a clinician to advance and retract thedelivery system 6300 through the patient's heart. In a particular use,the delivery system 6300 is advanced transapically over a guide wirethrough the left ventricle of a patient's heart after having beeninserted through a puncture in the left ventricle.

The delivery system 6300 includes a prosthetic valve sheath 6390positioned in the interior of the introducer sheath 6302. The prostheticvalve sheath 6390 comprises an elongated shaft 6392 that encloses aprosthetic valve delivery outer catheter 6360, a prosthetic valvedelivery inner catheter 6365, and a compressed prosthetic valve 6370.The shaft 6392 of the prosthetic valve sheath 6390 terminates at an opendistal end and can be configured to be moveable axially relative to theother shafts of the delivery system 6300 (e.g., using a handle or lever(such as a lockable handle or lever) located at or near a proximal endof the delivery system 6300 as is known in the art). Furthermore, in theillustrated embodiment, the shaft 6392 is the outermost catheter withinthe introducer sheath 6302.

The prosthetic valve delivery outer catheter 6360 has an elongated shaft6362 and an outer fork 6364 connected to a distal end portion of theshaft 6362. The shaft 6362 of the prosthetic valve delivery outercatheter 6360 can be configured to be moveable axially relative to theother shafts of the delivery system 6300 (e.g., using a handle or lever(such as a lockable handle or lever) located at or near a proximal endof the delivery system 6300 as is known in the art). Furthermore, theshaft 6362 of the prosthetic valve delivery outer catheter 6360 can besized so that its exterior wall is adjacent to or in contact with theinner wall of the shaft 6392 of the prosthetic valve sheath 6390.

The prosthetic valve delivery inner catheter 6365 can have an elongatedshaft 6366 and an inner fork 6368 secured to the distal end portion ofthe shaft 6366. The shaft 6366 of the inner catheter 6365 can beconfigured to be moveable axially relative to the other shafts of thedelivery system 6300 (e.g., using a handle or lever (such as a lockablehandle or lever) located at or near a proximal end of the deliverysystem 6300 as is known in the art).

A self-expanding prosthetic valve 6370 (e.g., a THV) is in a compressedor unexpanded state and is contained within the prosthetic valve sheath6390. The prosthetic valve 6370 can be any suitable self-expandableprosthetic heart valve, such as those described in U.S. PatentApplication Publication Nos. 2007/0112422 (U.S. application Ser. No.11/280,063) and 2010/0049313 (U.S. application Ser. No. 12/429,040),which are expressly incorporated herein by reference. Furthermore, inthe embodiment illustrated in FIG. 63, the prosthetic valve includesretaining arms 6371, 6373, and 6375, which are engaged with the prongsof the outer fork 6364 of the prosthetic valve delivery outer catheter6360 and the inner fork 6368 of the prosthetic valve delivery innercatheter 6365 in the manner described above with respect to FIGS. 5 and6 and as described in U.S. Patent Application Publication No.2010/0049313 (U.S. application Ser. No. 12/429,040), which is expresslyincorporated herein by reference. To deploy the prosthetic valve 6370 inthe illustrated embodiment, the introducer sheath 6302 is withdrawn sothat the stent 10 can be positioned in the proper location adjacent tothe outflow side of an aortic valve, and the prosthetic valve sheath6390 is withdrawn to reveal the valve 6370. These actions can beperformed, for example, using one or more control handles or mechanisms(not shown) located at the proximal end of the delivery system 6300.These actions cause the prosthetic valve 6370 to be advanced outwardlythrough the distal end 6395 of the prosthetic valve sheath 6390 and toexpand into its relaxed, uncompressed state. In the illustratedembodiment, the prosthetic valve 6370 is shown as being positionedconcentrically with the support stent 10. In other embodiments, however,the support stent 10 can be positioned distally of the prosthetic valve6370.

In the illustrated embodiment, the delivery system 6300 further includesa stent delivery outer fork catheter 6308 and a stent delivery innerfork catheter 6318. In the illustrated embodiment, the stent deliveryinner fork catheter 6318 comprises a stent delivery inner fork 6338secured to a distal end of an elongated shaft 6320. The shaft 6320 canbe sized to fit within the prosthetic valve delivery inner catheter6365. The shaft 6320 can be configured to be moveable axially relativeto the other shafts in the delivery system 6300 (e.g., using a handle orlever (such as a lockable handle or lever) located at or near a proximalend of the delivery system 6300 as is known in the art). Furthermore,the shaft 6320 can be sized so that its exterior wall is adjacent to orin contact with the inner wall of the shaft 6366 of the prosthetic valvedelivery inner catheter 6360.

The stent delivery outer fork catheter 6308 comprises a stent deliveryouter fork 6340 secured to a distal end of an elongated shaft 6310. Inthis embodiment, the shaft 6310 of the stent delivery outer forkcatheter 6308 is sized to fit within the stent delivery inner forkcatheter 6318. The shaft 6310 of the stent delivery outer fork catheter6308 can be configured to be moveable axially relative to the othershafts of the delivery system 6300 (e.g., using a handle or lever (suchas a lockable handle or lever) located at or near a proximal end of thedelivery system 6300 as is known in the art). Furthermore, the shaft6310 of the stent delivery outer catheter 6308 can be sized so that itsexterior wall is adjacent to or in contact with the inner wall of theshaft 6320 of the stent delivery inner fork catheter 6318. (Note thatthis is in contrast to the delivery system 5600 described above in whichthe stent delivery outer catheter 5608 has a larger circumference thanthe stent delivery inner catheter 5618 and at least partially enclosesthe stent delivery inner catheter 5618.)

The stent delivery system 6300 further includes a nose cone catheter6352 having a distal end to which the nose cone 6350 is secured. Forexample, a distal portion of the nose cone 6350 can be attached to thedistal end of the nose cone catheter 6352. The nose cone 6350 can beattached to the nose cone catheter 6352, for instance, using a suitableadhesive, a frictional engagement mechanism (e.g., a snap-fit orthreaded collar attachment), by forming the nose cone 6350 and the nosecone catheter 6352 as part of a single unibody element (e.g., usingsuitable molding techniques), or other such attachment mechanism. In theillustrated embodiment, shaft 6356 of the nose cone catheter 6352 can besized so that its exterior wall is adjacent to or in contact with theinner wall of the shaft 6310 of the stent delivery outer fork catheter6308. Furthermore, the shaft 6356 of the nose cone catheter 6352 can beconfigured to be moveable axially relative to the other shafts of thedelivery system 6300 (e.g., using a handle or lever (such as a lockablehandle or lever) located at or near a proximal end of the deliverysystem 6300 as is known in the art). Additionally, the nose conecatheter 6352 can define an interior lumen through a guide wire 6380 canextend. For instance, a guide wire 6380 can be inserted through the nosecone catheter 6352 such that it extends through a distal end 6351 of thenose cone 6350.

In FIG. 63, the support stent 10 is shown in a radially compressed statein the interior of the elongated shaft 6304 of the introducer sheath6302. In this undeployed and compressed state, the prongs of the outerfork 6340 and the inner fork 6338 of the stent delivery outer forkcatheter 6308 and the stent delivery inner fork catheter 6318 engage theretaining arms 21, 23, 25 of the support stent 10 in the mannerdescribed above with respect to FIGS. 5 and 6. To deploy the supportstent 10 in the illustrated embodiment, the introducer sheath 6302 iswithdrawn over the support stent 10 using one or more control handles ormechanisms (not shown) located at the proximal end of the introducersheath 6302. When the introducer sheath 6304 is withdrawn over thesupport stent 10, the support stent can expand into its relaxed,uncompressed state (shown, for example, in FIGS. 1 and 2).

As more fully illustrated below in FIGS. 64-70, a prosthetic valve(e.g., a THV) can be delivered to the aortic valve entirely through atransapical approach (e.g., through the apex of the heart and throughthe left ventricle) using the deployment system 6300. The prostheticvalve 6370 can be deployed transapically within the native valve suchthat the prosthetic valve is secured in place by frictional engagementbetween the support stent, the native leaflets, and the prostheticvalve. As explained above with reference to FIGS. 4 and 5, the supportstent 10 can be shaped so that the native leaflets of the aortic valvebecome trapped or pinched between the support stent 10 and the exteriorof the prosthetic valve 6370 when the prosthetic valve is expanded anddeployed within the native valve. The deployment system 6300 can beused, for example, to deliver a support stent 10 to treat aorticinsufficiency, as well as any other condition in which the aorta oraortic valve may not be in condition to help support the prostheticvalve (e.g., when the aortic annulus is too dilated or in which theleaflets of the aorta are too weak or soft to support the prostheticvalve).

FIGS. 64-70 illustrate one exemplary procedure for deploying the supportstent and securing a prosthetic valve (e.g., a THV) to the support stentusing the delivery system 6300 or other such transapical deliverysystem. In particular, FIGS. 64-70 are cross-sectional views through theleft side of a patient's heart showing the acts performed in deliveringthe support stent 10 through the left ventricle and into the annulus ofthe aortic valve. In order to better illustrate the components of thedelivery system 6300, the introducer sheath 6302 and the nose cone 6350are shown partially cut away in FIGS. 64-70.

FIG. 64 shows the introducer sheath 6302 and the nose cone 6350 of thedelivery system 6300 as they are advanced toward the aortic valve 6410.FIG. 64 also shows the outer fork 6340 of the stent delivery outer forkcatheter 6308, the inner fork 6338 of the stent delivery inner forkcatheter 6318, the prosthetic valve sheath 6390, the outer fork 6364 ofthe prosthetic valve delivery outer catheter 6360, the inner fork 6368of the prosthetic valve delivery inner catheter 6365, and the supportstent 10. In FIG. 64, the introducer sheath 6302 is advanced in thedirection of guidewire 6380, which is shown as being extended throughthe aortic valve 6410.

The introducer sheath 6302 and the nose cone 6350 are advanced over theguidewire 6380 through the annulus of the aortic valve 6410. Inparticular, the nose cone 6350 is advanced so that the support stent 10is located in a position that is above the native leaflets of the aorticvalve when the valve is open.

As shown in FIG. 65, the introducer sheath 6302 can be withdrawnproximally so that the introducer sheath no longer surrounds the stentdelivery inner fork catheter 6318, the stent delivery outer forkcatheter 6308, and the support stent 10. However, as shown in FIG. 65,the prosthetic valve sheath 6390 can continue to enclose the compressedprosthetic valve 6370. With the introducer sheath 6302 withdrawn, thesupport stent 10 is no longer held within the inner walls of theintroducer sheath 6302 and expands into its uncompressed, natural shapein a position on the outflow side of the aortic valve 6410. In FIG. 65,the support stent 10 is self-expanding. In other embodiments, however,the support stent 10 may not be self-expanding. In such embodiments, thesupport stent 10 can be made of a suitable ductile material, such asstainless steel. In addition, a mechanism for expanding the supportstent can be included as part of the delivery system 6300. For example,and as explained above with respect to FIG. 8, the support stent can bedisposed around a balloon of a balloon catheter in a compressed state

In FIG. 65, the stent delivery outer fork catheter 6308 and the stentdelivery inner fork catheter 6318 are positioned so that the supportstent 10 is placed adjacent to or directly on the surface of the outflowside of the aortic valve. The support stent 10 is rotated and positionedas necessary so that the support stent generally circumscribes theaortic valve and so that the peaks of the support stent are aligned withthe tips of the natural leaflets of the aortic valve 6410. Therefore,when the prosthetic valve 6370 is expanded within the aortic valve 6410,the leaflets of the aortic valve will engage at least the majority ofthe surface in the interior of the support stent 10. In otherembodiments, the support stent 10 is rotated and positioned as necessaryso that the peaks of the support stent 10 are aligned with thecommissures or other portions of the aortic valve. The position of theintroducer sheath 6302, the nose cone 6350, the prosthetic valve 6370,and the support stent 10 relative to the aortic valve 6410, as well asthe position of other elements of the system, can be monitored usingradiopaque markers and fluoroscopy, or using other imaging systems suchas transesophageal echo, transthoracic echo, intravascular ultrasoundimaging (“IVUS”), or an injectable dye that is radiopaque.

Also seen in FIG. 65 are the prongs of the outer fork 6340 and theprongs of the inner fork 6338. In the exemplary procedure, the prongs ofthe outer fork 6340 and the inner fork 6338 remain secured to thesupport stent 10 until the prosthetic valve is deployed and frictionallyengaged to the support stent. The inner and outer forks desirably form aconnection between the stent 10 and the delivery system that is secureand rigid enough to allow the clinician to hold the stent 10 at thedesired implanted position against the flow of blood while theprosthetic valve is being implanted.

Also seen in FIG. 65 is the valve delivery sheath 6390, which isadvanced into the aortic valve 6410 so that the prosthetic valve 6370 islocated within the interior of the annulus of the aortic valve andwithin the interior of the expanded support stent 10 (e.g.,concentrically with the annulus of the aortic valve and the expandedsupport stent 10). Radiopaque markers may be provided on the prostheticvalve sheath 6390, the prosthetic valve delivery outer catheter 6360,and/or the prosthetic valve delivery inner catheter 6365 to moreaccurately determine the position of the valve 6370 relative to thesupport stent 10 and the aortic valve 6410. In some embodiments, theclinician can adjust the position of the valve 6370 by actuating asteering or deflecting mechanism within the prosthetic valve sheath6360, the prosthetic valve delivery outer catheter 6360, and/or theprosthetic valve delivery inner catheter 6365. Furthermore, therotational orientation of the valve 6370 can be adjusted relative to thecusps and commissures of the native aortic valve by twisting theprosthetic valve sheath 6390, the prosthetic valve delivery outercatheter 6360, and/or the prosthetic valve delivery inner catheter 6365from their proximal end and observing specific markers on the valve (orany of the catheters) under fluoroscopy. At the point in the exemplaryprocedure illustrated in FIG. 65, the compressed support stent 6370 isready to be expanded into the aortic valve 6410. In order to betterillustrate the components of the delivery system for the prostheticvalve, FIGS. 65-70 show the front third of the support stent 10 and thefront of the prosthetic valve 6370, but do not show the portions of thenative heart valve that would be secured by the front of the supportstent 10. It is to be understood, however, that a corresponding leafletof the native heart valve would be secured between the support stent 10and the prosthetic valve 6370.

In FIG. 66, the prosthetic valve sheath 6390 (not visible in FIG. 66) isretracted such that the self-expandable prosthetic valve expands toengage the leaflets of the aortic valve 6410. Consequently, the leafletsof the aortic valve are urged against the inner wall of the supportstent 10. In other words, the expansion of the prosthetic valve 6370pinches the leaflets of the aortic valve 6410 between the support stent10 and the prosthetic valve 6370, thereby securing the prosthetic valvewithin the annulus of the aortic valve.

As shown in FIG. 67, once the prosthetic valve 6370 is secured into itsdesired position, the prosthetic valve delivery inner catheter 6365 ofthe delivery system 6300 can be retracted, thereby causing the prongs ofthe inner fork 6368 to become disengaged from the retaining arms of theprosthetic valve 6370. Once the prongs of the inner fork 6368 aredisengaged, the prongs of the outer fork 6364 become disengaged from theretaining arms, and the prosthetic valve delivery outer catheter 6360can be retracted.

With the prosthetic valve 6370 now disengaged, the stent delivery innerfork catheter 6318 of the delivery system 6300 can be advanced distally,thereby causing the prongs of the inner fork 6338 to become disengagedfrom the retaining arms of the support stent 10. Once the prongs of theinner fork 6338 are disengaged, the prongs of the outer fork 6340 becomedisengaged from the retaining arms, and the stent delivery outer forkcatheter 6308 can be advanced distally. In other embodiments, thesupport stent 10 is disengaged from the delivery system 6300 first, orthe support stent 10 and the prosthetic valve 6370 are disengaged atleast partially simultaneously.

As shown in FIG. 68, once the support stent 10 and the prosthetic valve6370 are disengaged from the delivery system 6300, the introducer sheath6302 can be advanced over the prosthetic valve outer catheter 6360 andthe prosthetic valve inner catheter 6365. The nose cone 6350 can also beretracted so as to partially enclose the stent delivery outer forkcatheter 6318 and the stent delivery inner fork catheter 6318.

As shown in the FIG. 69, the introducer sheath 6302 can then be advancedto entirely enclose the prosthetic valve outer catheter 6360 and theprosthetic valve inner catheter 6365, and thereby aid the removal of thecatheters from the aortic valve 6410. The introducer sheath 6302 (alongwith all of the interior catheters) and the nose cone 6350 can thenretracted through the prosthetic valve 6370. The delivery system 6300can then be removed from the ventricle of the patient. The guide wire6380 can also be withdrawn from the patient as well, leaving theprosthetic valve 6370 securely positioned within the aortic valve 6310by the support stent 10 as shown by FIG. 70.

Embodiments of a Collapsible Nose Cone

The nose cones that are used with any of the embodiments describedherein can have a variety of shapes, sizes, and properties. In certainembodiments, for example, the nose cone can be configured to becollapsible. For instance, the nose cone can be adapted to beself-expanding in its natural state, but be collapsible into acompressed configuration when the nose cone is retracted within asurrounding catheter.

FIG. 71A is a front view of the distal end portion of an exemplary stentdelivery system 7100 comprising a collapsible nose cone. The stentdelivery system 7100 is similar to the apparatus 100 shown in FIGS. 3and 4 and shows the support stent 10 in a compressed, predeployed state.The delivery system 7100 comprises a main catheter 7102 having anelongated shaft 7104, whose distal end 7105 is open in the illustratedembodiment. The delivery system 7100 also includes a stent deliverycatheter 7108 positioned in the interior of the main catheter 7102. Thestent delivery catheter 7108 has an elongated shaft 7110 and an outerfork 7140 connected to a distal end portion of the shaft 7110. Thedelivery system 7100 also includes an inner catheter 7118 positioned inthe interior of the stent deliver catheter 7108 and configured to beaxially and rotatably movable relative to the other shafts of thedelivery system 7100 (e.g., using a handle or lever (such as a lockablehandle or lever) located at or near a proximal end of the deliverysystem 7100 as is known in the art). The inner catheter 7118 can have anelongated shaft 7120 and an inner fork 7138 secured to the distal endportion of the shaft 7120. The delivery system 7100 further includes anose cone catheter 7155 positioned in the interior of the inner catheter7118 and configured to be axially and rotatably movable relative to theother shafts of the delivery system 7100 (e.g., using a handle or lever(such as a lockable handle or lever) located at or near a proximal endof the delivery system 7100 as is known in the art). The nose conecatheter 7155 has an elongated shaft 7156 and a nose cone 7150 connectedto a distal end portion of the shaft 7156. The nose cone 7150 can beconnected to the shaft 7156 using a suitable adhesive (e.g., a bondingadhesive), a frictional engagement mechanism (e.g., a snap-fit orthreaded collar attachment), by forming the nose cone 7150 and the nosecone catheter 7155 as part of a single unibody element (e.g., usingsuitable molding techniques), or other such attachment mechanism. Thenose cone catheter can further include a guide wire lumen 7158 throughwhich a guide wire, such as guide wire 7180, can be advanced. The guidewire 7180 can be used, for example, to help ensure proper advancement ofthe main catheter 7102 and its interior catheters through thevasculature of a patient.

In the illustrated embodiment, the collapsible nose cone 7150 isgenerally football-shaped. More generally, the illustrated nose cone7150 can be said to form an ellipsoid whose polar radius (in they-direction) is greater than the equatorial radius (in the x-direction).Such a shape can also be referred to as a spindle-shaped ellipsoid or aprolate spheroid. In the illustrated embodiment, the collapsible nosecone 7150 is formed from a wire mesh (or stented mesh) of a suitableshape-memory metal or alloy, such as spring steel, Elgiloy®, or Nitinol.During manufacture, the nose cone 7150 can be cut and heat treated sothat it takes the desired nose cone shape but also has some flexibilityto reduce trauma to the patient's vasculature. Furthermore, when thenose cone 7150 is made from a shape-memory metal or alloy, a protectivecovering can be used to cover the nose cone 7150 and further reduce anytrauma to the patient's vasculature when the nose cone 7150 is advancedthrough it. For instance, the nose cone 7150 can be covered in a thinpolymer or cloth cover (not shown). In other embodiments, the nose cone7150 can be formed from a suitable foam that can compressed to a smallerstate. In general, the nose cone 7150 can be fabricated from anymaterial that allows the nose cone to automatically expand to itsfunctional size and shape when deployed but also allows the nose cone tobe radially compressed to a smaller profile.

FIG. 71B is a front view showing the support stent 10 after it has beenadvanced from the distal end of the main catheter 7102. As seen in FIG.71B, the support stent 10 now assumes its relaxed, uncompressed shapebut remains connected to the outer fork 7140 and the inner fork 7138 atits retaining arms 21, 23, 25. FIG. 71B also shows the nose conecatheter 7155 withdrawn into the interior lumen of the inner catheter7118. When the nose cone catheter 7155 is withdrawn into the innercatheter 7118, the collapsible nose cone 7150 is urged into itscompressed state by the inner walls of the inner catheter 7118. In thiswithdrawn state, the nose cone 7150 is no longer located distally of thesupport stent 10, the outer fork 7140, or the inner fork 7138.Consequently, the support stent 10 can be positioned into the properlocation adjacent to the aortic valve without any interference caused bythe nose cone 7150. Furthermore, when a prosthetic valve is delivered tothe aortic valve, the nose cone 7150 does not block or otherwiseinterfere with the placement of the prosthetic valve.

Although the compressible nose cone 7150 is shown as being used with astent delivery system 7100 similar to that shown in FIGS. 3-4, it can beused with any of the delivery systems disclosed herein. A compressiblenose cone can be used in such a system to aid guidance through thepatient's vasculature, but can then be retracted into an interior lumenof the system so that the distal end of the system can be free from anyinterference the nose cone might otherwise cause.

Alternative Support Stent Designs

FIGS. 72-107 illustrate various alternative embodiments for the supportstent that can be used together with any of the delivery systemsdescribed herein. The features shown in support stents illustrated inFIGS. 72-107 can be used alone or in various combination andsubcombinations with one another as appropriate. The support stents inFIGS. 72-107 can have a generally annular or toroidal body formed from asuitable shape-memory metal or alloy, such as spring steel, Elgiloy®, orNitinol. Desirably, the material from which the support stents arefabricated allows the support stent to automatically expand to itsfunctional size and shape when deployed but also allows the supportstent to be radially compressed to a smaller profile for deliverythrough the patient's vasculature. In other embodiments, however, thestent is not self expanding.

FIGS. 72-74 illustrate a support stent 7200 in which each peak includestwo spaced-apart strut members. In particular, FIG. 72 is a perspectiveview of the support stent 7200, FIG. 73 is a top view of the supportstent 7200. In the illustrated embodiment, the support stent 7200includes six peaks and six valleys, although it should be noted thatmore or fewer peaks and valleys can be included in the support stentdepending on the design. Furthermore, for ease of illustration,retaining arms (such as retaining arms 21, 23, 25 in FIG. 1) are omittedfrom the support stent 7200. It should be understood that retaining armscan be included on any one or more of the peaks of the support stent7200 and be configured for use with a release mechanism associated witha corresponding support stent delivery system (e.g., using the mechanismdescribed above with respect to FIGS. 5 and 6).

As seen in FIGS. 72 and 73, a respective peak 7210 includes an upperstrut member 7212 and a lower strut member 7214. The upper strut member7212 and the lower strut member 7214 can be separated by an aperture7220 in the respective peak 7210 of the support stent 7200. For example,the aperture 7220 can extend along a majority of the respective peak7210. The aperture 7220 can begin at a point of the support stent 7200near a first adjacent valley 7230 and extend centrally through therespective peak 7210 to a point near a second adjacent valley 7232. Theaperture 7220 can be manufactured into the support stent using asuitable milling or molding technique.

FIG. 74 is a partial front view of the valley 7230 further illustratingthe construction of the aperture 7220 as well as an adjacent aperture7222. FIG. 74 illustrates that the upper and lower strut members 7212,7214 can be said to be connected at the valley 7230.

As best seen in FIGS. 72 and 73, the lower strut members (such as lowerstrut member 7214) are angled outwardly relative to the upper strutmembers (such as upper strut member 7212). Thus, the lower strut membersform outer strut members and the upper strut members form inner strutmembers. Thus, the peaks of the lower strut members collectively definea diameter that is larger than the diameter collectively defined by thepeaks of the upper strut members. In other embodiments, the upper strutmembers are angled outwardly relative to the lower strut members. Instill other embodiments, only some of the upper strut members are angledoutwardly relative to the lower strut members, or vice versa. Inparticular embodiments, the upper strut members can be configured sothat they collectively define an annular interior having a diameter thatapproximately matches (or is slightly smaller than) the diameter of theprosthetic valve with which the support stent 7200 is to be used. Forexample, the interior defined by the upper strut members can beconfigured to be slightly smaller than the diameter of the prostheticvalve in its expanded state, thus helping to create a tighter fit withthe prosthetic valve when the support stent 7200 is deployed. The lowerstrut members can be angled and configured so that their peakscollectively define a diameter that is substantially the same as thediameter of the aortic annulus. In particular embodiments, the angle andlength of the lower strut members can be selected so that the lowerstrut members engage the leaflets of the aortic valve alongsubstantially the entire length of each leaflet or at another pointalong each leaflet (e.g., at points in the aortic annulus where thecommisure between two adjacent leaflets ends). In general, the outerstrut members (e.g., the lower strut members in support stent 7200) canengage and urge together portions of the valve leaflets that are nototherwise engaged by the inner strut members (e.g, the upper strutmembers in support stent 7200). This helps reduce paravalvular leakageby reducing gaps between the valve leaflets.

FIG. 75 shows an embodiment of a support stent 7500 similar to that ofsupport stent 7200 except that the space between the upper strut members(such as respective upper strut member 7512) and the lower strut members(such as respective lower strut member 7514) of the peaks (such asrespective peak 7510) are covered by a cloth or other impermeablematerial 7522. The impermeable material 7522 creates an additionalbarrier to help prevent valve leakage.

FIG. 76 shows an embodiment of a support stent 7600 similar to that ofsupport stent 7200 except that the upper (and, in this embodiment,outer) strut members include projections that define interior spacesconfigured to enclose portions of adjacent valve leaflets. In theillustrated embodiment, the interior spaces defined by the projectionsextend into the apertures between the upper strut members and the lower(and inner) strut members of the support stent 7600. In certainembodiments, the interior spaces defined by the projections can have adifferent width (e.g., a smaller width) than the apertures. For example,in FIG. 76, a respective peak 7610 includes an upper strut member 7612and a lower strut member 7614. The upper strut member 7612 further formsa projection 7640 that includes an interior space 7642 betweenrespective sides of the projection. In the illustrated embodiment, theprojection is U-shaped but can have other shapes as well (e.g., 0-shape,half-mooned-shape, semicircular, hook-shape or other such shapes).

When positioned adjacent to the outflow side of a patient's aortic valveand frictionally engaged to the leaflets of the aortic valve via theexpansion of a prosthetic valve in the central interior of the supportstent 7600, the upper strut member 7612 and the lower strut member 7614can engage adjacent valve leaflets as shown in FIG. 77. In particular,FIG. 77 is a perspective view showing a first aortic valve leaflet 7750and a second aortic valve leaflet 7752 captured in the interior of theprojection 7640. As a result, the aortic valve leaflets 7750, 7752 arecaused to coapt with each other along commissure 7760, thus helping toreduce or substantially eliminate paravalvular leaking through theleaflets. Also shown in FIG. 77 is expanded prosthetic valve 7770, whichhas an exterior surface that captures (or pinches) a portion of thefirst aortic valve leaflet 7750 and the second aortic valve leaflet 7752against the upper strut member 7612 of the support stent 7600.

FIG. 154 shows an embodiment of a support stent 15400 similar to that ofsupport stent 7600 but includes a cover 15410 that extends between upperstrut member 15412 and lower strut member 15414. The cover 15410 can becloth, silicone, foam, or some other biocompatible material. In certainembodiments, the cover is secured to the frame by stitching 15411 orsome other fastening mechanism (e.g., one or more sutures). The cover15410 can operate to further reduce the paravalvular leaking throughleaflets of the aortic valve, such as through first aortic leaflet 15450and second aortic leaflet 15452.

FIG. 78 shows an embodiment of a support stent 7800 similar to that ofsupport stent 7200 except that the aperture between the upper strutmembers and the lower strut members extends through the valleys of thesupport stent 7800. For example, an upper strut member 7812 is separatedfrom a lower strut member 7814 by an aperture 7820 that extends througha majority of valley 7830. Furthermore, the upper strut member 7812 andthe lower strut member 7814 are connected at a location in peak 7810.

FIG. 79 shows an embodiment of a support stent 7900 similar to that ofsupport stent 7800 except that an interior 7942 formed between adjacentsides of a lower strut member 7914 in a peak 7910 has a smaller widththan an interior 7944 formed between adjacent sides of an upper strutmember 7912 in a valley 7930 of the support stent 7900. The peak 7910 ofthe support stent 7900 can be said to be generally cusp-shaped. Thereduced width in the interior 7942 of the peak 7910 allows the supportstent 7900 to pinch adjacent leaflets of the patient's aortic valve moreclosely, thereby reducing any potential leakage between the twoleaflets.

When positioned adjacent to the outflow side of a patient's aortic valveand frictionally engaged to the leaflets of the aortic valve via theexpansion of a prosthetic valve in the central interior of the supportstent 7900, the upper (and, in this embodiment, inner) strut member 7912and the lower (and, in this embodiment, outer) strut member 7914 canengage adjacent valve leaflets as shown in FIG. 80. In particular, FIG.80 is a perspective view showing a first aortic valve leaflet 8050 and asecond aortic valve leaflet 8052 captured in the interior 7942 formedbetween adjacent sides of the lower strut member 7914. As a result, theaortic valve leaflets 8050, 8052 are caused to coapt with each otheralong commissure 8060, thus helping to reduce or substantially eliminateparavalvular leaking through the leaflets. Also shown in FIG. 80 isexpanded prosthetic valve 8070, which has an exterior surface thatcaptures (or pinches) a portion of the first aortic valve leaflet 8050and the second aortic valve leaflet 8052 against the upper strut member7912 of the support stent 7900 as the upper strut member 7912 extendsthrough valley 7930 of the support stent 7900.

FIGS. 81-82 show another embodiment of a support stent 8100. In FIGS. 81and 82, the upper strut members for a given peak are disconnected fromone another at the ends of the members closest to the peak. For example,for peak 8110, the upper strut members comprise a first upper strut arm8112 and an adjacent second upper strut arm 8113. Each of the upperstrut arms 8112, 8113 are connected to the support stent 8100 atlocations 8132, 8133 located at or near valleys 8130, 8131. The upperstrut arms 8112, 8113 can further comprise head portions 8116, 8117having a generally circular shape at the ends of the upper strut arms8112, 8113, respectively. The upper strut arms 8112, 8113 can have avariety of lengths, but in certain embodiments the upper strut arms8112, 8113 extend higher along the support stent 8100 than the othercomponents of the support stent. The support stent 8100 further includeslower strut members that are continuous and not divided into separatearms. For example, for respective peak 8110, the support stent 8100includes a lower strut member 8114 that has a generally sinusoidalshape.

FIG. 81 shows the support stent 8100 before the support stent is setinto its final shape (e.g., using a suitable shape set technique forshape memory alloys). FIG. 82 shows the support stent 8100 after it hasbeen shape set into one exemplary configuration. In the configurationshown in FIG. 82, the first upper strut arm 8112 is configured to becrossed with the second upper strut arm 8113, thereby forming aninterior 8144 having an apex 8145. Furthermore, the crossed upper strutarms 8112, 8113 can be configured to be angled outwardly relative to thelower strut member 8114. Thus, the crossed upper strut arms 8112, 8113can form outer strut arms, where as the lower strut member 8114 can forman inner strut member.

When positioned adjacent to the outflow side of a patient's aortic valveand frictionally engaged to the leaflets of the aortic valve via theexpansion of a prosthetic valve in the central interior of the supportstent 8100, the first upper strut arm 8112, the second upper strut arm8113, and the lower strut member 8114 can engage adjacent valve leafletsas shown in FIG. 83. In particular, FIG. 83 is a perspective viewshowing a first aortic valve leaflet 8350 and a second aortic valveleaflet 8352 captured in an interior 8144 formed between the first upperstrut arm 8112 and the second upper strut arm 8113. In particular, thefirst upper strut arm 8112 and the second upper strut art 8113 can causethe aortic valve leaflets 8350, 8352 to be urged together at or near theapex 8145 of the interior 8144 formed between the upper strut arms alongcommissure 8360, thus helping to reduce or substantially eliminateparavalvular leaking through the leaflets. Also shown in FIG. 83 isexpanded prosthetic valve 8370, which has an exterior surface thatcaptures (or pinches) a portion of the first aortic valve leaflet 8350and the second aortic valve leaflet 8352 against the lower strut member8114 of the support stent 8100.

FIGS. 84-85 show another embodiment of a support stent 8400. In FIGS. 84and 85, the upper strut members for a given peak are comprised of upperstrut arms that are connected by a connecting member at the distal endof the upper strut arms. For example, for peak 8410, the upper strutmembers comprise a first upper strut arm 8412 and an adjacent secondupper strut arm 8413. Each of the upper strut arms 8412, 8413 areconnected to the support stent 8400 at locations 8432, 8433 located ator near valleys 8430, 8431. In this embodiment, the upper strut arms8412, 8413 are connected to one another by a connecting member 8416. Theupper strut arms 8412, 8413 can have a variety of lengths, but incertain embodiments the upper strut arms 8412, 8413 extend higher alongthe support stent than the other components of the support stent 8400.In certain embodiments, the upper strut arms 8412, 8413 and theconnecting member 8416 shape the upper strut member of the support stent8400 into a top-hat (or mesa) shape. The support stent 8100 furtherincludes lower strut members that are continuous and not divided intoseparate arms. For example, for respective peak 8410, the support stent8400 includes a lower strut member 8414 that has a generally sinusoidalshape.

FIG. 85 shows the support stent 8400 before the support stent is setinto its final shape (e.g., using a suitable shape set technique forshape memory alloys). FIG. 85 shows the support stent 8500 after it hasbeen shape set into one exemplary configuration. In the configurationshown in FIG. 85, the first upper strut arm 8412 is configured to becrossed with the second upper strut arm 8413, thereby forming adiamond-shaped interior 8444. Furthermore, the crossed upper strut arms8412, 8413 can be configured to be angled outwardly relative to thelower strut member 8414. Thus, the crossed upper strut arms 8412, 8413can form outer strut arms, where as the lower strut member 8414 can forman inner strut member.

FIG. 86 shows an embodiment of a support stent 8600 having six peaks andsix valleys. In particular, support stent 8600 has a generallysinusoidal shape forming six peaks (e.g., peak 8610) and six valleys(e.g., valley 8612). Furthermore, each of the peaks of the support stent8600 includes a retaining arm (e.g., retaining arm 8614). In otherembodiments, however, fewer than all of the peaks can comprise aretaining arm. For instance, every other peak can include a retainingarm. Additionally, the support stent can alternatively include anynumber of peaks or valleys.

FIG. 87 shows an embodiment of a support stent 8700 that is similar tosupport stent 8600 but includes covers 8720 that enclose at least aportion of one or more valleys of the support stent 8700. In theillustrated embodiment, a plurality of covers 8720 enclosessubstantially all of each valley in the support stent 8700, includingthe interior space of the valley defined between adjacent strut membersof the support stent (e.g., interior space 8730 between first strutmember 8732 and adjacent second strut member 8734). In otherembodiments, the covers 8720 enclose only some of the valleys in thesupport stent 8700. Furthermore, the covers 8720 can form a completeenclosure or can be open at a top end, thus forming a basket-type cover.The covers 8720 can comprise cloth coverings and may define a hollowinterior into which additional padding or other material can beinserted. The covers 8720 can also be formed from silicone, foam, orsome other biocompatible material. In certain embodiments, wires orother support bands (e.g., wire 8736) are positioned between adjacentstrut members of a valley at or near the adjacent peaks of the valley.For instances, the wires or support bands can be threaded througheyelets (not shown) formed in the support stent 8700. The upper ends ofthe covers 8720 can be attached to the wires or support bands (e.g.,using a suitable stitch or other attachment mechanism). Consequently,the covers 8720 can be held in place when the support stent is in acompressed state. Desirably, the covers 8720 are adapted to create alarger surface area of the support stent 8700 that engages the nativeleaflets of the heart valve when the support stent 8700 is inserted.This larger surface area reduces the overall force experienced betweenthe native valve leaflets and the support stent 8700, making the fitbetween the native valve leaflets and the support stent 8700 lesstraumatic to the native valve leaflets. In certain embodiments,additional padding (e.g., additional or thicker cloth, silicone, orfoam) can be placed at or near the nadir (or base) of the valleys of thesupport stent 8700 (e.g., additional padding within each of the covers8720 at a location adjacent to the nadir of a valley).

FIG. 88 shows an embodiment of a support stent 8800 that is similar tosupport stent 8600 but includes tubular covers 8820 that enclose atleast some of the support stent. In the illustrated embodiment, aplurality of tubular covers 8820 encloses substantially all of eachvalley in the support stent 8800. In other embodiments, the tubularcovers 8820 enclose only some of the valleys in the support stent 8800.Furthermore, the tubular covers 8820 can form a complete enclosure overthe body of the support stent 8800 in the desired locations. In otherembodiments, however, the tubular covers 8820 can have an open side orportion (e.g., the covers 8820 can be C-shaped or cover just one side ofthe support stent) The tubular covers 8820 can comprise tubular clothcoverings and may define a hollow interior into which additional paddingor other material can be inserted. The tubular covers 8820 canalternatively be formed from silicone, foam, or some other biocompatiblematerial. Desirably, the tubular covers 8820 are adapted to provide asofter surface that engages the native leaflets of the heart valve whenthe support stent is inserted. The tubular covers 8820 also create alarger surface area of the support stent 8800, thereby reducing theoverall force that is experienced between the native valve leaflets andthe support stent 8800. In certain embodiments, additional padding(e.g., additional or thicker cloth, silicone, or foam) can be placed ator near the nadir (or base) of the valleys of the support stent 8800(e.g., additional padding within each of the tubular covers 8820 at alocation adjacent to the nadir of a valley).

FIG. 89 shows an embodiment of a support stent 8900 that is similar tosupport stent 8600 but includes foot projections 8920 positioned at oradjacent to the nadir of the valleys of the support stent 8900. The footprojections 8920 can be formed to be an integral part of the body of thesupport stent 8900 or can comprise separate members that are attached tothe support stent 8900 (e.g., using a suitable adhesive or bondingagent, mechanical fastener, or other attachment mechanism). In stillother embodiments, the foot projections 8920 can be part of a coveringthat covers the body of the support stent 8900. For example, inparticular implementations, the foot projections 8920 are part of anovermold that is molded over a body 8902 of the support stent 8900. Theovermold can be formed of a suitable biocompatible material (e.g.,silicone) that helps reduce the trauma between the support stent 8900and the native valve leaflets. The shape of the foot projections 8920can vary from implementation to implementation, but in theimplementation illustrated in FIG. 89 comprises a tongue-shapedprojection that is outwardly flanged. Furthermore, in the illustratedembodiment, six foot projections 8920 are shown. In other embodiments,more or fewer foot projections are present. In general, the footprojections 8920 create a larger surface area at the bottom of thesupport stent 8900 where the support stent 8900 engages the uppersurface of the outflow side of a patient's aortic valve. The increasedsurface area created by the foot projections 8920 helps distribute theoverall force that is experienced between the native valve leaflets andthe support stent 8900, making the support stent 8900 less traumatic tothe native heart valve. The foot projections 8920 can also be used toengage a side wall of the aortic valve, which is typically more durableand less sensitive to trauma as the tissue of the native leaflets of apatient's heart valve.

FIG. 90 shows an embodiment of a support stent 9000 having footprojections 9020 that are integrally formed as part of the body of thesupport stent 9000. The foot projections 9020 are generallytongue-shaped but curve outwardly and then upwardly so as to have aU-shaped (or hook-shaped) profile. Although the foot projections 9020are integrally formed as part of the support stent 9000, the footprojections can alternatively be separate members that are attached tothe body of the support stent. Furthermore, in the illustratedembodiment, six foot projections 9020 are shown. In other embodiments,more or fewer foot projections are present. Each of the foot projections9020 optionally includes one or more apertures 9022 (only tworepresentative ones of which are shown in FIG. 90). The apertures 9022can also improve the compressibility of the support stent 9000 so thatthe foot projections do not substantially affect the diameter to whichthe support stent 9000 can be compressed during delivery. In use, theapertures 9022 can also help increase the friction between a respectivefoot projection and the surface of the native heart valve (e.g., thesurface of the aortic annulus), and thereby help prevent the supportstent 9000 from rotating out of its desired petition. In general, thefoot projections 9020 create a larger surface area at the bottom of thesupport stent 9000 where the support stent 9000 engages the uppersurface of the outflow side of a patient's aortic valve. The increasedsurface area created by the foot projections 9020 helps distribute theoverall force that is experienced between the native valve leaflets andthe support stent 9000, making the support stent 9000 less traumatic tothe native heart valve. The foot projections 9020 can also be used toengage a side wall of the aortic valve, which is typically more durableand less sensitive to trauma as the tissue of the native leaflets of apatient's heart valve.

FIG. 91 shows an embodiment of a support stent 9100 having loopprojections 9120 that are integrally formed as part body of the supportstent 9100. The loop projections 9120 extend outwardly from the diameterof a main body portion 9102 of the support stent 9100. Furthermore, inthe illustrated embodiment, each of the loop projections 9120 isconnected to the support stent 9100 at locations at or near the nadirsof adjacent valleys of the support stent 9100. For example, a respectiveone of the loop projections 9120 has ends that merge with the main bodyportion 9102 of the support stent 9100 at a first location 9104 near afirst nadir 9105 and at a second location 9106 near a second nadir 9107.Although the loop projections 9120 are integrally formed as part of thesupport stent 9100, the loop projections can alternatively be separatemembers that are attached to the body of the support stent. Furthermore,in the illustrated embodiment, three loop projections 9120 are shown. Inother embodiments, more or fewer loop projections are present. Ingeneral, the loop projections 9120 create a larger surface area at thebottom of the support stent 9100 where the support stent 9100 engagesthe upper surface of the outflow side of a patient's aortic valve. Theincreased surface area created by the loop projections 9120 helpsdistribute the overall force that is experienced between the nativevalve leaflets and the support stent 9100, making the support stent 9100less traumatic to the native heart valve. The loop projections 9120 canalso be used to engage a side wall of the aortic valve, which istypically more durable and less sensitive to trauma as the tissue of thenative leaflets of a patient's heart valve.

For any of the embodiments described above, the support stent canadditionally include a cover or coating that helps lessen the trauma toa native heart valve and/or further increase the surface area of thesupport stent. For example, the cover or coating can be formed fromcloth, silicone, foam, or some other biocompatible material. Inparticular embodiments, the support stents include an overmold of asuitable biocompatible material (e.g., silicone) or are dipped to have acoating of a suitable biocompatible material. Additionally, and asexplained above with respect to FIG. 89, the foot projections or loopprojections of any of the described embodiments can be formed as part ofa mold or covering that surrounds the main body of the support stent.

Furthermore, for any embodiment that includes a covering or cover of anytype, combinations of materials can be used to form the covering. Forexample, a multi-material cover or covering can be used that providesadded padding or softness to certain desired portions of the supportstent, whereas the remainder of the cover or covering may include athinner material. For instance, a thicker (or softer) material can beused to form an inward-facing side of the cover (a side of the coverthat faces the interior of the support stent and engages the nativevalve leaflets) whereas a thinner material can be used to form anoutward-facing side of the cover (a side of the cover that faces towardthe walls of the heart valve). Additionally, for any embodiment thatincludes a covering or cover of any type, multiple layers of a materialcan be used to form the cover. The multiple layers can comprise one ormore different materials. For example, in certain embodiments, two ormore materials are sewn together and used to create a fabric that isused to form the covers for the support stent. For instance, a thickcloth material can be sewn to a thin cloth material, resulting in amulti-layer, multi-material fabric. This fabric can then be used to formany of the covers described herein. By using such a multi-layered andmulti-material fabric, the cover can have an interior fabric (the fabricthat contacts the main body of the support stent) that is different thanan exterior fabric (the fabric that is on the outside of the cover andfaces the surrounding native heart valve or prosthetic valve). Forinstance, the interior fabric can be a thick fabric and the exteriorfabric can be a thin fabric, or vice versa. The covering can also bedesigned to cover only certain desired surfaces of the support stent.For example, in certain embodiments, covering material is only locatedon the inner (or inward-facing) surface of the support stent. Suchembodiments provide abrasion protection to the native leaflets butreduce the quantity of extra material added to the support stent, thusreducing the crimped profile of the support stent. In other embodiments,the covering material surrounds both the inward-facing andoutward-facing surface of some portion of the support stent but onlycover an inward-facing surface of other portions of the support stent.For example, the lower portion of the support stent body can becompleted covered (including its inward- and outward-facing surface)whereas the remaining portion of the support stent body can be eitheruncovered or covered only on its inward-facing surface. Further, for anyembodiment that includes a covering or cover of any type, pockets can besewn into or otherwise formed in the interior of the covering or cover.The pockets can be sized to receive corresponding valleys and/or peaksof the support stent, thereby helping to secure the cover or covering tothe support stent. Exemplary embodiments of support stents that havecovers with at least some of the above features are described below withrespect to FIGS. 92-103 and 108-109. It should be understood, however,than any of these features can be utilized with any of the covers orcoverings described herein.

FIGS. 92-94 show an embodiment of a support stent 9200 whose main body9202 is covered by a multi-material cover 9204. In particular, FIG. 92is a perspective view of the support stent 9200, FIG. 93 is a top viewof the support stent 9200, and FIG. 94 is a bottom of the support stent9200. The multi-material cover 9204 comprises an outward-facing portion9210 formed of a first material that is cut and shaped to cover the mainbody 9202 along its outward-facing (or exterior) side and aninward-facing portion 9212 formed of a second material that is cut andshaped to cover the main body 9202 along its inward-facing (or interior)side. The first material can be a thinner material relative to thesecond material. For example, the first material can be a thin clothfabric, whereas the second material can be a thick cloth fabric. Themulti-material cover 8204 can be formed by sewing the outward-facingportion 9210 to the inward-facing portion 9212 at a top seam 9220 and abottom seam 9222. Eyelets can be formed in the multi-material cover 9204to allow the retaining mechanisms (such as retaining mechanism 9206) tobe exposed through the multi-material cover. The added thickness in theinward-facing portion 9212 can reduce the trauma experienced by theleaflets of the native heart valve when a prosthetic valve is expandedin the interior of the support stent 9200, thereby pinching the leafletsof the native heart against the inward-facing portion 9212. Furthermore,the thin fabric used on the outward-facing portion 9210 helps maintainthe compressibility of the support stent 9200. Consequently, the supportstent 9200 can be delivered to the native heart using a delivery systemhaving a desirably small diameter. In certain embodiments, additionalpadding can be inserted between the main body 9202 of the support stent9200 and the interior of the multi-material cover 9204. Furthermore, anysuitable biocompatible material can be used to form the portions of themulti-material cover (e.g., silicone, cloth, or other such biocompatiblematerials).

FIG. 99 is a side view of support stent member 9900 covered by anembodiment of a multi-material cover 9910. In particular, themulti-material cover 9910 comprises an inward-facing side 9912 and anoutward-facing side 9914. The inward-facing side 9912 of the cover 9910is the side that pinches a native valve leaflet to the exterior of anexpanded prosthetic valve, whereas the outward-facing side 9914 is theside that faces outwardly from the support stent in the direction of thesurrounding aortic valve walls. The inward-facing side 9912 can comprisea thicker, or more padded, material (e.g., a thick cloth), whereas theoutward-facing side 9914 can comprise a thinner, less or less padded,material (e.g., a thinner cloth). In certain embodiments, the thicker,or more padded material, is more specifically positioned on a cover forthe support stent. For example, and as illustrated schematically in FIG.100, a cover can comprise thicker, more padded material, in locations ofthe support stent that are inward-facing and adjacent or near a nadir ofa support stent valley. Location 10010 illustrates one such location inthe nadir of the support stent valley 10020. By using a cover that onlyhas the thicker material on its inward-facing side or in locations ofthe support stent where added padding is desirable (such as in theinterior of the stent adjacent to the nadirs of the support stentvalleys), the support stent can have padding to reduce the traumaexperienced by the native valve leaflets but can also have a profilewhen the support stent is compressed that allows the support stent to beinserted into a suitable delivery system (e.g., any of the deliverysystems described above).

FIG. 95 shows an embodiment of a support stent 9500 whose main body 9502is covered by a cover 9504. As shown in FIG. 95, the cover 9504 enclosessubstantially all of the main body 9502 except for the retainingmechanisms (e.g., retaining mechanism 9506). Any suitable biocompatiblematerial can be used to form cover 9504 (e.g., silicone, cloth, or othersuch biocompatible materials). In the illustrated embodiment, foampadding 9510 is inserted into the cover 9504. In particular, foampadding is added to the cover 9504 at or near each of the nadirs of thevalleys of the support stent. For example, the cover 9504 is stuffedwith a suitable foam stuffing or inserted at a location of the coveradjacent to nadir 9520. The added thickness at the nadirs of the valleysof the support stent 9500 can help reduce the trauma experienced by theleaflets of the native heart valve when a prosthetic valve is expandedin the interior of the support stent 9500, thereby bending the leafletsat the nadirs of the support stent 9500 and pinching the leaflets of thenative heart against interior sides of the support stent.

FIG. 96 shows an embodiment of a support stent 9600 whose main body 9602is covered by a cover 9604 except for the retaining mechanisms (e.g.,retaining mechanism 9606). The cover 9604 encloses at least a portion ofone or more valleys of the support stent 9600. In the illustratedembodiment, the cover 9604 encloses substantially all of each valley inthe support stent 9600, including the interior space of the valleydefined between adjacent strut members of the support stent (e.g.,interior space 9630 between first strut member 9632 and adjacent secondstrut member 9634). The cover 9604 can form a complete enclosure or canbe open at a top end, thus forming a basket-type cover. The cover 9604can comprise a cloth covering and may defines a hollow interior intowhich additional padding or other material can be inserted. The cover9604 can also be formed from silicone, foam, or some other biocompatiblematerial. In the illustrated embodiment, the cover 9604 is formed byjoining individual covers (e.g., covers 9610, 9612) together (e.g., besewing the covers 9610, 9612 together). Furthermore, the cover 9604includes pockets (e.g., pockets 9620, 9622) in the interior of the cover9604 that are configured to receive and hold the cover 9604 to the mainbody 9602 of the support stent 9600. In one exemplary process, the cover9604 can be fabricated by first cutting two V-shaped pieces that have anoutline corresponding to the valleys of the support stent. Someadditional material (e.g., about 1 mm) can be left around the edge ofeach piece. Two fractional-V-shaped pieces are also cut. Thefractional-V-shaped pieces have the same shape as the V-shaped piecesbut have less than the full height of the V-shaped pieces (e.g., onlyhalf of the height of the V-shaped pieces). The two fractional-V-shapedpieces are set on top of the V-shaped pieces, and all four pieces aresewn together on their lateral edges (the top of the pieces is leftopen). The resulting cover is then inverted so that thefractional-V-shaped pieces form an interior pocket into which arespective valley of the support stent 9600 can be inserted. Covers forthe other valleys of the support stent 9600 can be formed in a similarfashion. The tops of the covers can then be sewn or otherwise connectedtogether, thereby forming a complete cover 9604. As more fully explainedabove with respect to FIG. 87, wires or other support bands can bepositioned between adjacent strut members of a valley at or near theadjacent peaks of the valley to provide a support for holding the cover9604 in position. Desirably, the cover 9604 creates a larger surfacearea of the support stent 9600 that engages the native leaflets of theheart valve when the support stent is inserted. This larger surface areareduces the overall force experienced between the native valve leafletsand the support stent 9600, thus making the fit between the native valveleaflets and the support stent less traumatic to the native valveleaflets. In certain embodiments, additional padding (e.g., additionalor thicker cloth, silicone, or foam) can be placed within the cover 9604(e.g., at or near the nadir of the valleys of the support stent 9600).

FIG. 97 shows an embodiment of a support stent 9700 similar to supportstent 9600 but with a cover 9704 that includes portions that extendbelow the bottom of the main body of the support stent 9700. In theillustrated embodiment, the cover 9704 has three portions that extendbelow the main body of the support stent, corresponding to the threenative leaflets of an aortic valve. For example, the cover 9704 includesa portion 9720 formed over adjacent valleys of the support stent andalso over the peak that is defined between the adjacent valleys.Furthermore, the portion 9720 is generally V-shaped and has a bottom end9722 that extends below the bottom of the support stent 9700. In theillustrated embodiment, the portion 9720 further includes interiorpockets 9710, 9712 into which adjacent valleys (e.g., valleys 9730,9732) of the support stent can be inserted. The cover 9704 can becreated in a manner similar to that described above for FIG. 96 but withpieces sized and shaped to form the portions that extend below thebottom of the main body of the support stent 9700. As with theembodiment of FIG. 96, the cover 9704 creates a larger surface area ofthe support stent 9700 that engages the native leaflets of the heartvalve when the support stent is inserted. For example, the portions ofthe cover 9704 that extend below the main body help distribute thestress caused by the support stent more evenly, thus making the supportstent less traumatic, and also help hold the support stent in itsdesired position. Additionally, the portions of the cover 9704 that arelocated near the native comissures of the native valve leaflets canprovide a further barrier between the outflow and inflow side of theaortic valve, thereby helping to prevent paravalvular leakage.Additional padding (e.g., additional or thicker cloth, silicone, orfoam) can be placed within the cover 9704 (e.g., at or near the nadir ofthe valleys of the support stent 9700 or at or near the bottom end9722).

FIG. 98 shows an embodiment of a support stent 9800 similar to supportstent 9700 but with a cover 9804 that includes portions that extendbelow the bottom of the main body of the support stent 9800. In theillustrated embodiment, the cover 9804 has three portions that extendbelow the main body of the support stent, corresponding to the threenative leaflets of an aortic valve. For example, the cover 9804 includesa portion 9820 formed partially over adjacent valleys of the supportstent 9800 and also partially over the peak that is defined between theadjacent valleys. As shown in FIG. 98, peaks of the support stent 9800(such as peaks 9840, 9842) can be entirely enclosed by the cover exceptfor the retaining mechanisms. The portion 9820 is generally V-shaped andhas a bottom end 9822 that extends below the bottom of the support stent9800. In the illustrated embodiment, the portion 9820 further includesinterior pockets 9810, 9812 into which adjacent valleys (e.g., valleys9830, 9833) of the support stent can be inserted. The cover 9804 can becreated in a manner similar to that described above for FIG. 96 but withpieces sized and shaped to form the portions that extend below thebottom of the main body of the support stent 9800. As with theembodiment of FIG. 96, the cover 9804 creates a larger surface area ofthe support stent 9800 that engages the native leaflets of the heartvalve when the support stent is inserted. For example, the portions ofthe cover 9804 that extend below the main body help distribute thestress caused by the support stent more evenly, thus making the supportstent less traumatic, and also help hold the support stent in itsdesired position. Additionally, the portions of the cover 9804 that arelocated near the native comissures of the native valve leaflets canprovide a further barrier between the outflow and inflow side of theaortic valve, thereby helping to prevent paravalvular leakage.Additional padding (e.g., additional or thicker cloth, silicone, orfoam) can be placed within the cover 9804 (e.g., at or near the nadir ofthe valleys of the support stent 9800 or at or near the bottom end9822).

In other embodiments, one or more portions of the covering arepositioned solely on the inward-facing surface of the support stent. Forexample, FIG. 108 shows an embodiment of a support stent 10800 that issimilar to support stent 8800 shown in FIG. 88 but has covers (e.g.,covers 10820) positioned only on the inward-facing surface of thesupport stent 8800. The covers can comprise cloth coverings and maydefine a hollow interior into which additional padding or other materialcan be inserted. The covers can alternatively comprise padding formedfrom silicone, foam, or some other biocompatible material. The covers10820 can be attached to the support stent 10800 using a variety ofmechanisms, including stitching around the support stent 10800, abiocompatible adhesive, or other attachment mechanism. Desirably, thecovers 10820 are adapted to provide a softer surface that engages thenative leaflets of the heart valve when the support stent is inserted.In certain embodiments, additional padding (e.g., additional or thickercloth, silicone, or foam) can be placed at or near the nadir (or base)of the valleys of the support stent 10800.

Furthermore, in certain embodiments, the covers can be configured tosurround both the inward-facing and outward-facing surface of someportion of the support stent while other portions of the support stenthave only their inward-facing surface covered. For example, the lowerportion of the support stent body (e.g., the lower 2 mm of the supportor approximately the lower 2 mm of the support stent) can be completelycovered (including its inward- and outward-facing surface) whereas theremaining portion of the support stent body can be either uncovered orcovered only on its inward-facing surface. For instance, FIG. 155 showsan embodiment of a support stent 15500 that has a cover 15502 thatcovers more of the inward-facing surface of the support stent body thanthe outward-facing surface. The cover 15502 can comprise a clothcovering. Further, the cover can define a hollow interior into whichadditional padding or other material can be inserted, or the cover canjust cover a frame 15504 of the support stent 15500 as illustrated. Thecover 15502 can alternatively comprise padding formed from silicone,foam, or some other biocompatible material. The cover 15502 can beattached to the support stent 15500 using a variety of mechanisms,including stitching around the frame 15504 of the support stent, abiocompatible adhesive, or other attachment mechanism. In theillustrated embodiment, and as seen at 15508, the cover 15502 coversboth the inward-facing side and the outward-facing side of the frame15504 at locations at or near the nadir (or base) of the valleys of thesupport stent 15500 (e.g., the cover 15502 can cover the lower 1-10 mmof the frame 15504). However, and as seen at 15506, the cover 15502covers more of the inward-facing side of the frame 15504 than theoutward-facing side. For example, the cover 15502 can coversubstantially all of the inward-facing side of the frame 15504, asillustrated, or can cover any portion of the inward-facing side greaterthan the outward-facing side. Further, the cover 15502 can be formed sothat is does not cover the eyelets of the frame 15504 (such as eyelet15512). In the illustrated embodiment, the upper portion of the cover15502 is held to the frame 15504 by stitching (e.g., stitching 15510).Desirably, the cover 15502 is adapted to provide a softer surface thatengages the native leaflets of the heart valve when the support stent isinserted. In certain embodiments, additional padding (e.g., additionalor thicker cloth, silicone, or foam) can be placed at or near the nadir(or base) of the valleys of the support stent 15500.

FIG. 109 shows another embodiment of a support stent 10900 similar tosupport stent 9700 shown in FIG. 97 but with a cover 10904 that ispositioned only on the inward-facing surface of the support stent 10900.In the illustrated embodiment, the cover 10904 has three portions thatextend below the main body of the support stent, corresponding to thethree native leaflets of an aortic valve. For example, the cover 10904includes a portion 10920 that spans across adjacent valleys of thesupport stent and also over the peak that is defined between theadjacent valleys. Furthermore, the portion 10920 is generally V-shapedand has a bottom end 10922 that extends below the bottom of the supportstent 10900. The covers 10904 can be attached to the support stent 10900using a variety of mechanisms, including stitching around the supportstent 10900, a biocompatible adhesive, or other attachment mechanism.The cover 10904 creates a larger surface area of the support stent 10900that engages the native leaflets of the heart valve when the supportstent is inserted. Additional padding (e.g., additional or thickercloth, silicone, or foam) can be at or near the nadir of the valleys ofthe support stent 10900 or at or near the bottom end 10922. Furthermore,in certain embodiments, the cover can be configured to surround both theinward-facing and outward-facing surface of some portion of the supportstent while other portions of the support stent have only theirinward-facing surface covered. For example, the lower portion of thesupport stent body (e.g., the lower 2 mm of the support stent orapproximately the lower 2 mm of the support stent) can be completelycovered (including its inward- and outward-facing surface) whereas theremaining portion of the support stent body can be either uncovered orcovered only on its inward-facing surface.

In certain embodiments, the cover for the support stent or for a portionof the support stent is configured to be moved into place upon expansionof the support stent. An exemplary mechanism 10100 for moving a coverfor a valley of a support stent into place upon expansion of the supportstent is illustrated in FIG. 101. The mechanism 10100 comprises a cover10110 having a pin member 10112 that extends across the interior of thecover (e.g., from an inward-facing of the cover to an outward-facingside of the cover). The pin member 10112 is located above a respectivevalley 10120 of support stent 10102. The mechanism 10100 furtherincludes a wire or thread 10130 that is strung between a first retainingmechanism head 10140 and a second adjacent retaining mechanism head10142 in a criss-cross fashion. To enable the illustrated criss-crossthreading, the first retaining mechanism head 10140 includes a firsteyelet 10141 and the second retaining mechanism head 10142 includes asecond eyelet 10143 through which the wire or thread 10130 is threaded.The wire or thread 10130 can alternatively be strung in a straight loop(without any criss-cross) between the retaining mechanisms heads 10140,10142. The wire or thread 10130 is further configured so that it extendsinto the interior of the cover 10110 below the pin member 10112. FIG.101 shows the mechanism 10100 as the support stent 10102 is expandingand the wire or thread 10130 engages the pin member 10112 and pulls thecover 10110 taut against the frame of the support stent. FIGS. 102 and103 show the mechanism when the support stent 10102 is in a compressedstate. In particular, FIG. 102 is a front view of the mechanism 10100and FIG. 103 is a side view of the mechanism. As seen in FIG. 102,portions of the cover 10110 can be disposed below the support stent10102 when the support stent is in its compressed state. This allows thecompressed support stent 10102 to be compressed more tightly in itscompressed state. Furthermore, when the support stent 10102 is loadedinto the interior of a catheter in a suitable delivery system (such asany of the delivery systems described above), the support stent 10102can be loaded first followed by one or more covers (such as cover10110). In other words, the support stent 10102 and its associatedcovers can be loaded serially.

FIGS. 104-107 show a variety of different designs that can be used toform any of the support stents described above. In general, the designsshown in FIGS. 104-107 can help increase the compressibility of thesupport stent, thereby allowing the support stent to be delivered in adelivery system having a desirably small diameter. The designs can alsohelp increase the strength of the support stents. It should be notedthat the designs FIGS. 104-107 show the stent designs as if they wereunrolled and flattened. It should be understand, however, that inpractice the stent designs would be annular in shape as described abovewith respect to FIGS. 1 and 2. Furthermore, for ease of illustration,the stent designs in FIGS. 104-107 omit the one or more retaining armsthat may be formed at one or more of the peaks of the support stent andthat allow for the support stent to be released coupled to one or morecatheters of the delivery system.

FIG. 104 shows a stent design 10400 in which one or more struts of thestent include ends having enlarged circular heads. For example, strut10420 is integrally connected to a first enlarged circular head 10410and an opposite second enlarged circular head 10412. The circular heads(e.g., circular heads 10410, 10412) allow for the struts of the stent tobe more easily compressed without causing undue stress or fatigue at thepeaks and valleys of the support stent. In the stent design 10400illustrated in FIG. 104, each of the peaks and valleys has a uniform (orapproximately uniform) height.

FIG. 105 shows a stent design 10500 similar to that shown in FIG. 104except that adjacent circular heads of the support stent have differentheights. For example, enlarged circular head 10510 at a first peak ofthe stent design 10500 has a different height than adjacent enlargedcircular head 10514 at an adjacent second peak. Similarly, enlargedcircular head 10512 at a first valley of the stent design 10500 has adifferent height than adjacent enlarged circular head 10516 at anadjacent valley. The heads can be said to have staggered heights. Thisdesign allows the struts of the design (e.g., strut 10520) to be furthercompressed because adjacent circular heads in the stent design 10500 donot contact each other at their widest points when the support stent iscompressed.

FIG. 106 shows a stent design 10600 that is similar to that shown inFIG. 105 except that the stent design includes clover-shaped heads atthe ends of the respective struts. For example, strut 10620 isintegrally connected to a first enlarged clover-shaped head 10610 and anopposite second enlarged clover-shaped head 10612. The clover-shapedheads (e.g., clover-shaped heads 10610, 10612) also allow for the strutsof the stent to be more easily compressed without causing undue stressor fatigue at the peaks and valleys of the support stent. In the stentdesign 10600 illustrated in FIG. 106, the peaks and valleys havestaggered heights as with stent design 10500 shown in FIG. 105.

FIG. 107 shows a stent design 10700 in which one or more of the peaks orvalleys has an arch-shape. For example, the stent design 10700 includesan arch-shaped peak 10710 (a gothic-arch-shaped peak in the illustrateddesign). The arch shapes of the one or more peaks allow for the strutsof the stent (e.g., strut 10720) to be more easily compressed withoutcausing undue stress or fatigue at the peaks and valleys of the supportstent. In the stent design 10700 illustrated in FIG. 107, each of thepeaks and valleys has a uniform (or approximately uniform) height. Inother designs, the peaks and valleys have staggered heights as withstent design 10500 shown in FIG. 105.

Exemplary Embodiments of Support Stent Delivery Aids

Accurate delivery of a support stent to a patient's heart valve cansometimes be challenging. For example, in certain circumstances, thesupport stent may be positioned such that it surrounds some, but notall, of the native heart valve leaflets. Furthermore, the support stentmay not be oriented correctly relative to the native heart valveleaflets. In such situations, the support stent may not properly securethe prosthetic heart valve to the native valve leaflets, resulting in anunstable prosthetic heart valve and undesirable paravalvular leakage.Accordingly, for certain embodiments of the disclosed technology,support stent delivery aids are desirable. The embodiments described inthis section include systems and mechanisms that aid in the delivery ofa support stent by stabilizing the native heart valve leaflets duringthe delivery process and/or increasing the visibility of the locationsof the native leaflets. Furthermore, it should be understood thatalthough the exemplary systems described in this section are describedand illustrated as being transapically deployed, any of the systems canbe transfemorally deployed. For example, any of the systems can beincorporated into any of the transfemoral support stent delivery systemsdescribed above (e.g., by incorporating one or more additional cathetersinto any of the systems) or as an independent delivery system that isdeployed at least partially simultaneously with any of the support stentdelivery systems.

FIG. 110 is a cross-sectional view through the left side of a patient'sheart illustrating operation of an embodiment of a leaflet stabilizingsystem 11000. In particular, the leaflet stabilizing system 11000comprises a main catheter 11002 having an elongated shaft whose distalend is open in the illustrated embodiment. The leaflet stabilizingsystem 11000 includes a leaflet stabilizer outer catheter 11010positioned in the interior of the main catheter 11002 and a leafletstabilizer inner catheter 11012 positioned in the interior of theleaflet stabilizer outer catheter 1110. The leaflet stabilizer outercatheter 11010 and the leaflet stabilizer inner catheter 11012 areconfigured to be axially and rotatably movable relative to one anotheras well as relative to the main catheter 11002 (via two or more lockablehandles or levers located at or near the proximal end of the leafletstabilizing system 11000 (not shown)). In the illustrated embodiment, anend cap 11020 is located at a distal end of the leaflet stabilizer innercatheter 11012. Stabilizer arms 11030, 11032, 11034 extend from a lowerportion or edge of the end cap 11020 toward the proximal end of thesystem 11000. In other embodiments, the stabilizer arms 11030, 11032,11034 are not coupled to the end cap 11020, but are coupled to thedistal end of the leaflet stabilizer inner catheter 11012 or to anotherpiece or component coupled to the distal end of the leaflet stabilizerinner catheter 11012. The stabilizer arms 11030, 11032, 11034 can beformed from a shape-memory alloy (e.g., Nitinol) and be shape set toextend outwardly from the shaft of the leaflet stabilizer inner catheter11012 at an angle (e.g., an approximately 20-, 33-, or 45-degree angle,or any other angle relative to the shaft of the leaflet stabilizer innercatheter 1112). The stabilizer arms 11030, 11032, 11034 can further becoated or covered with a radiopaque substance in order to improve thevisualization of the stabilizer arms during deployment. The stabilizerarms 11030, 11032, 11034 can further include respective loop portions(or hook portions) 11031, 11033, 11035 at their free ends (referred toas their distal ends). The stabilizer arms 11030, 11032, 11034 canfurther be pivotally coupled to the distal end of the leaflet stabilizerouter catheter 11010 via one or more pivot arms. A representative pivotarm 11040 is referenced in FIG. 110. The one or more pivot arms can beconfigured to pivot at one of or both of the distal end of the leafletstabilizer outer catheter 11010 or a region of the respective stabilizerarm near the end cap. The pivot arms (such as pivot arm 11040) arepositioned and configured to create an umbrella-arm mechanism that drawsthe stabilizer arms radially inward when the leaflet stabilizer outercatheter 11010 is moved axially toward the proximal end of the system11000 relative to the leaflet stabilizer inner catheter 11012, and thatextends the stabilizer arms radially outward when the leaflet stabilizerouter catheter 11010 is moved axially toward the distal end of thesystem (toward the end cap 11020) relative to the leaflet stabilizerinner catheter 11012.

In use, the main catheter 11002 of the leaflet stabilizer system 11000is extended transapically through a puncture in the patient's leftventricle. During this time, the stabilizer arms 11030, 11032, 11034 canbe pulled against the shaft of the leaflet stabilizer outer catheter11010 and retracted inside the interior of the main catheter 11002. Thedistal end of the system 11000 can be positioned adjacent to the inflowside of the aortic valve. The leaflet stabilizer outer catheter 11010and the leaflet stabilizer inner catheter 11012 can then be extendeddistally through the leaflets of the aortic valve (two of which areshown as leaflets 11050, 11052) until the stabilizer arms are advancedcompletely through the aortic valve. During this process, the stabilizerarms 11030, 11032, 11034 can remain pulled against the shaft of theleaflet stabilizer outer catheter 11014 (via the pivot arms and therelative retraction of the leaflet stabilizer outer catheter 11010). Thestabilizer arms can then be urged radially outwardly by moving theleaflet stabilizer outer catheter 11010 distally relative to the leafletstabilizer inner catheter 11012, thereby causing the pivot arms to pushthe stabilizer arms 11030, 11032, 11034 radially outward. The leafletstabilizer outer catheter 11010 and the leaflet stabilizer innercatheter 11012 can then be retracted together until the loop portions11031, 11033, 11035 engage the surface of the valve leaflets (includingleaflets 11050, 11052).

To stabilize the leaflets into a position that allows for easiertransfemoral placement of the support stent (using, for example, any ofthe transfemoral support stent delivery systems described above), thestabilizer arms 11030, 11032, 11034 can then be drawn radially inward byretracting the leaflet stabilizer outer catheter 11010 relative to theleaflet stabilizer inner catheter 11012. This causes the leaflets to bepulled together and urged toward the center of the leaflet stabilizersystem, thereby suppressing the movement of the leaflets during thesystolic and diastolic phase of the patient's heartbeat. In thisstabilized position, a support stent can be more easily deployed so thatthe native valve leaflets are properly positioned in the interior of thesupport stent and aligned as desired. Furthermore, the stabilizer arms11030, 11032, 11034 can function as guide rails that further aid in thedeployment of a support stent. For example, the stabilizer arms 11030,11032, 11034 can act as guide rails that engage the peaks of the supportstent and cause the support stent to rotate into the correct position asthe support stent is advanced through the aortic arch onto the surfaceof the outflow side of the aortic valve. In particular, as the supportstent is advanced into position, the frame of the support stent willengage the stabilizer arms 11030, 11032, 11034 and rotate the supportstent due to its sinusoidal shape until the stabilizer arms engage thesupport stent at the apices of respective peaks of the support stent.This action causes the support stent to rotate to a position that isaligned with the stabilizer arms 11030, 11032, 11034.

To further aid in the positioning of the support stent, the stabilizerarms 11030, 11032, 11034 can be rotated into a proper position withinthe aortic valve by rotating the system 11000 or by rotating the leafletstabilizer outer catheter 11010 and the leaflet stabilizer innercatheter 11012. This rotation can occur when the support stent isdeployed from a support stent delivery catheter (such as any of thesupport stent delivery catheters introduced above) and when the supportstent is engaged with the stabilizer arms 11030, 11032, 11034. To allowfor easier rotation, the prongs of the support stent delivery systemthat are used to retain and disengage the support stent can bemanufactured to be flexible. By using the stabilizer system 11000 to aidin the rotation of the support stent on the outflow side of the aorticvalve, rotation of the support stent is made easier. For example, whendeployed, a transfemoral support stent delivery system (such as any ofthe transfemoral delivery systems described above) will include a numberof arches and bends in its overall shape. The numerous arches and bendsthat are present when the transfemoral support stent delivery system isdeployed can increase the frictional force within the system that mustbe overcome before rotation of the support stent can be achieved. Byusing the stabilizer system 11000 to affect rotation of the supportstent, the support stent can be more easily rotated because the leafletstabilizer system 11000 is typically a straight catheter that is muchshorter in length than the transfemoral support stent delivery system.

FIG. 111 is a cross-sectional top view of the patient's aortic valve inFIG. 110 with the stabilizer arms engaging the leaflets. In particular,FIG. 111 shows loop portions 11031, 11033, 11035 engaging leaflets11050, 11052, 11054 near their ends. FIG. 111 further shows that theleaflets 11050, 11052, 11054 can be drawn together and held in astabilized position that creates a large target area where the supportstent can be deployed and surround the leaflets. Although the leafletsare shown in FIG. 111 as being held against the shaft of the leafletstabilizer outer catheter 11014, the stabilizer arms 11030, 11032, 11034can be operated so that the leaflets are opened wider, thereby allowingblood to more easily flow through the valve during support stentdeployment while still stabilizing the leaflets.

FIG. 112 is also cross-sectional top view of a patient's aortic valvesimilar to FIG. 111. In FIG. 112, however, the loop portions 11031′,11033′, 11035′ have an alternative orientation. In particular, the loopportions 11031′, 11033′, 11035′ are configured to lie flat against theleaflets 11050, 11052, 11054, thereby creating a larger contact areawith the leaflets. As in FIG. 111, FIG. 112 shows that the leaflets11050, 11052, 11054 can be drawn together and held at a stabilizedposition that creates a large target area for the support stent.

FIG. 113 is a cross-sectional view through the left side of a patient'sheart illustrating operation of another embodiment of a leafletstabilizing system 11300. Leaflet stabilizing system 11300 is similar toleaflet stabilizing system 11000 and comprises a similar main catheter11302, leaflet stabilizer outer catheter 11310, leaflet stabilizer innercatheter 11312, and end cap 11320. In FIG. 113, stabilizer arms 11330,11332, 11334 are not formed from a wire, but instead include an uppersurface and a lower surface. In the illustrated embodiment, the uppersurface is flat or generally flat, though it can be curved or have someother surface contour. The stabilizer arms 11330, 11332, 11334additionally include inwardly-angled lip portions 11331, 11333, 11335 attheir distal ends that help the stabilizer arms securely engage thenative leaflets of the heart and also helps the stabilizer arms 11330,11332, 11334 be retracted into the main catheter 11302. In use, theleaflet stabilizing system 11300 operates in a fashion similar to theleaflet stabilizing system 11000. For example, the stabilizer arms11330, 11332, 11334 can function as guide rails that further aid in thedeployment of a support stent and can also be used to help rotate thesupport stent into its proper orientation when the support stent isdeployed transfemorally. The shape of the stabilizer arms in FIGS.110-113 should not be construed as limiting, however, as the stabilizerarms can have a wide variety of configurations. Furthermore, in certainembodiments, a ring or ring-shaped member is coupled to the distal endsof the stabilizer arms and can be configured so that the diameter of thering decreases as the stabilizer arms are retracted toward the leafletstabilizer outer catheter (e.g., using a telescoping configuration forthe ring).

FIG. 114 is a cross-sectional view through the left side of a patient'sheart illustrating operation of another embodiment of a leafletstabilizing system 11400 in which the stabilizing arms are retractableinto a nose cone. The leaflet stabilizing system 11400 comprises a maincatheter 11402 having an elongated shaft. The leaflet stabilizing system11400 further includes a leaflet stabilizer outer catheter 11410positioned in the interior of the main catheter 11402 and a leafletstabilizer inner catheter 11412 positioned in the interior of theleaflet stabilizer outer catheter 11410. The leaflet stabilizer outercatheter 11410 and the leaflet stabilizer inner catheter 11412 areconfigured to be axially and rotatably movable relative to one anotheras well as relative to the main catheter 11402 (via two or more lockablehandles or levers located at or near the proximal end of the leafletstabilizing system 11400 (not shown)). In the illustrated embodiment, anose cone 11420 is located at and coupled to a distal end of the leafletstabilizer inner catheter 11412. In the illustrated embodiment, and asmore fully shown in FIGS. 115-118, the nose cone 11420 is at leastpartially hollow. Stabilizer arms 11430, 11432, 11434 can be coupled toa distal end of the leaflet stabilizer outer catheter 11412 (or to anattachment or other component coupled to the leaflet stabilizer outercatheter 11412) and extend toward the proximal end of the system 11400.The stabilizer arms 11430, 11432, 11434 can be formed from ashape-memory alloy (e.g., Nitinol) and be shape set to extend outwardlyfrom the shaft of the leaflet stabilizer outer catheter 11410 at adesired angle. The stabilizer arms 11430, 11432, 11434 can furtherinclude respective loop portions (or hook portions) 11431, 11433, 11435at their distal ends, which can be oriented radially, circumferentially,or in any other orientation around the shaft of the leaflet stabilizerouter catheter 11410.

FIG. 115 is a front perspective view of the distal end of the leafletstabilizing system 11400 with the stabilizer arms 11430, 11432, 11434 inan un-deployed, retracted state within the nose cone 11420. The nosecone 11420 can be hollow or can include shaped sleeves configured toreceive the stabilizer arms 11430, 11432, 11434. FIG. 117, for example,is a cross-section view of a nose cone 11702 having shaped sleeves11704, 11706, 11708 sized to receive stabilizer arms and a lumen 11710sized to receive the leaflet stabilizer outer catheter 11410.

FIG. 116 is a front perspective view of the distal end of the leafletstabilizing system 11400 with the stabilizer arms 11430, 11432, 11434 ina deployed state. In FIG. 116, the leaflet stabilizer outer catheter11410 is retracted proximally relative to the leaflet stabilizer innercatheter 11412, thereby releasing the stabilizer arms 11430, 11432,11434 from the nose cone. In the illustrated embodiment, the stabilizerarms 11430, 11432, 11434 are shape set to extend radially outwardly fromthe leaflet stabilizer outer catheter 11412 at a desired angle.

The shape of the stabilizer arms 11430, 11432, 11434 shown in FIGS.114-116 should not be construed as limiting, as the stabilizer arms canhave a variety of shapes and orientations. For example, the stabilizerarms could be oriented so that the loop portions are orientedcircumferentially around the leaflet stabilizer outer catheter 11412(similar to the stabilizer arms shown in FIG. 112). Alternatively, thedistal ends of the stabilizer arms can form multiple loops, aclover-shape, or any other closed loop or open loop shape. For example,FIG. 118 is a front perspective view of the distal end of a leafletstabilizing system 11800 with stabilizer arms 11830, 11832, 11834 in adeployed state. In the illustrated embodiment, the stabilizer arms11830, 11832, 11834 have a generally leaf-shaped profile. Such wide,closed-loop shapes can allow the stabilizer arms 11830, 11832, 11834 toengage the native leaflets across a wider area, thereby creating greatercontrol over the native leaflets.

In use, and as best shown in FIG. 114, the main catheter 11402 of theleaflet stabilizer system 11400 is extended transapically through apuncture in the patient's left ventricle. The stabilizer arms 11430,11432, 11434 can be in their un-deployed state within the nose cone11420. For example, the leaflet stabilizer outer catheter 11410 can beextended distally relative to the leaflet stabilizer inner catheter11412 so that the stabilizer arms 11430, 11432, 11434 are enclosedwithin the nose cone 11420. The distal end of the system 11400 is thenpositioned adjacent to the inflow side of the aortic. The leafletstabilizer outer catheter 11410, the leaflet stabilizer inner catheter11412, and the nose cone 11420 can then be extended distally through theleaflets of the aortic valve (two of which are shown as leaflets 11450,11452) until the nose cone 11420 is advanced completely through theaortic valve. The nose cone 11420 can then be extended distally relativeto the leaflet stabilizer inner catheter 11412, thereby revealing thestabilizer arms and allowing them to extend radially outwardly. Theleaflet stabilizer outer catheter 11410 and the leaflet stabilizer innercatheter 11412 can then be retracted together until the loop portions11431, 11433, 11435 engage the outflow surface of the valve leaflets(including leaflets 11450, 11452). This causes the leaflets to be pulledtogether and urged toward the center of the leaflet stabilizing system,thereby suppressing the movement of the leaflets during the systolic anddiastolic phase of the patient's heartbeat. As with the embodiment shownin FIG. 111, the illustrated leaflet stabilizer system 11400 creates alarge target area where the support stent can be deployed and alignedwith the leaflets. Furthermore, and as with the embodiment illustratedin FIG. 111, the stabilizer arms 11430, 11432, 11434 can function asguide rails that further aid in the deployment of a support stent andcan also be used to help rotate the support stent into its properorientation when the support stent is deployed transfemorally.

FIG. 119 is a front view of a further exemplary leaflet stabilizingsystem 11900. In particular, FIG. 119 shows the leaflet stabilizingsystem 11900 when stabilizing arms 11930, 11932, 11934 are in aun-deployed state. The delivery system 11900 comprises a main catheter11902 (which can be a steerable guide catheter) having an elongatedshaft. In the illustrated embodiment, the main catheter 11902 comprisesthree stabilizer arm lumens 11910, 11912, 11914 that extendlongitudinally through the main catheter 11902 and to a distal end11904. FIG. 120 is a top view of the leaflet stabilizing system 11900and shows the relative arrangement of the stabilizer arm lumens 11910,11912, 11914 on the distal end 11904 of the main catheter 11902according to one embodiment. It should be understood that otherarrangements are also possible. Furthermore, although the illustratedembodiment shows three stabilizer arm lumens 11910, 11912, 11914, moreor fewer lumens can be included in other embodiments of the system11900. Furthermore, although the distal end 11904 of the illustratedembodiment is not tapered, the distal end can be tapered. Furthermore,embodiments of the system 11900 can also include a tapered nose coneportion (e.g., the distal end can include multiple “flaps” forming aprotective nose cone that can be urged apart when the stabilizer arms11930, 11932, 11934 are deployed.

The stabilizer arms 11930, 11932, 11934 extend through the stabilizerarm lumens 11910, 11912, 11914 and through a proximal end 11906 of thesystem 11900. In the illustrated embodiment, the stabilizer arms 11930,11932, 11934 are formed from a shape-memory alloy (e.g., Nitinol) andinclude a lumen. For example, the stabilizer arms 11930, 11932, 11934can be formed from thin-bore shape-memory alloy tubing that can act asan inflation lumen.

As more fully discussed below with respect to FIGS. 120 and 121, thestabilizer arms 11930, 11932, 11934 can be shape set so that thestabilizer arms extend radially outwardly and loop backward in theproximal direction of the system 11900 when the stabilizer arms aredeployed. In the illustrated embodiment, inflatable balloons 11931,11933, 11935 are affixed to the distal ends of the stabilizing arms11930, 11932, 11934. The inflatable balloons 11931, 11933, 11935 can beformed from a latex or other suitable biocompatible material.Additionally, the inflatable balloons 11931, 11933, 11935 can be atleast partially coated with radiopaque markings that allow the balloonsto be more easily viewed using suitable imaging techniques (e.g.,fluoroscopy). In some embodiments, a radiopaque agent is used to inflatethe balloons 11931, 11933, 11935, thereby making the balloons visibleusing suitable imaging techniques.

A proximal end of the main catheter 11902 includes a handle 11940 thatis coupled to the stabilizer arms 11931, 11933, 11935 and allows for thestabilizer arms to be uniformly deployed from or retracted into the maincatheter 11902. In other embodiments, the stabilizer arms can beindividually controlled. In the illustrated embodiment, the handle 11940further includes an inflation lumen 11942 which is fluidly coupled tothe lumens of the stabilizing arms 11930, 11932, 11934. Thus, theballoons 11931, 11933, 11935 can be inflated and deflated through theuse of the inflation lumen 11942. In other embodiments, the inflationlumen is located elsewhere on the system 11900. For example, the maincatheter 11902 can include an inflation lumen that is fluidly coupled tothe lumens of the stabilizing arms 11930, 11932, 11934. In oneparticular implementation, an inflation lumen located on the maincatheter 11902 can be fluidly coupled to a chamber in the main catheter11902 through which the stabilizing arms 11930, 11932, 11934 pass. Thestabilizing arms 11930, 11932, 11934 can include inflation aperturesbored into the sides of their bodies, thereby fluidly coupling thelumens of the stabilizing arms with the chamber and the inflation lumen.

In use, and as best shown in FIGS. 121 and 122, the main catheter 11902of the leaflet stabilizer system 11900 is extended transapically througha puncture in the patient's left ventricle. During this stage, thestabilizer arms 11930, 11932, 11934 can be in their un-deployed statewithin the main catheter 11902. The distal end 11904 of the maincatheter can be advanced through the native leaflets of the aortic valve(two of which are shown as leaflets 11950, 11952) until the distal endis positioned on the outflow side of the aortic valve. The stabilizerarms 11930, 11932, 11934 can then be advanced out of the main catheter11902 (e.g., by advancing the handle 11940 relative to the main catheter11902). In the illustrated embodiment, the stabilizer arms are formed ofa shape-memory allows that is shape set so that the stabilizer arms11930, 11932, 11934 extend radially outward from the main catheter 11902and loop back toward the surface of the outflow side of the aorticvalve. The stabilizer arms 11930, 11932, 11934 can be advanced until theballoons 11931, 11933, 11935 engage the outflow surface of the valveleaflets (including leaflets 11950, 11952).

As shown in FIG. 122, the balloons 11931, 11933, 11935 are inflated bypumping a suitable fluid into the lumens of the stabilizer arms 11930,11932, 11934 via the inflation lumen 11942. This causes the balloons11931, 11933, 11935 to expand and push the leaflets together. Asexplained above, the fluid used to inflate the balloons 11931, 11933,11935 can comprise a radiopaque agent, thereby increasing the visibilityof the balloons through suitable imaging techniques and allowing theballoons to be more precisely positioned relative to the leaflets of theaortic valve. The balloons 11931, 11933, 11935 further operate tosuppress the movement of the leaflets during the systolic and diastolicphase of the patient's heartbeat. As with the embodiment shown in FIG.111, the illustrated leaflet stabilizer system 11900 creates a largetarget area where the support stent can be deployed and aligned with theleaflets. Furthermore, and as in FIG. 111, the stabilizer arms 11930,11932, 11934 can function as guide rails that further aid in thedeployment of a support stent and can also be used to help rotate thesupport stent into its proper orientation when the support stent isdeployed transfemorally.

FIG. 123 is a perspective view of a further embodiment of a supportstent 12300 comprising a leaflet stabilizing mechanism. In theillustrated embodiment, the leaflet stabilizing mechanism is formed froma wire that extends between adjacent valleys of the support stent. Inparticular, the support stent 12300 shown in FIG. 123 includes a peakhaving a retaining arm 12320. As explained above, the retaining arm12320 can be releasably coupled to a support stent delivery system thatincludes an outer prong 12330 and a release wire 12332, which isthreaded through an aperture of the retaining arm when the retaining armis bent through an aperture of the outer prong. Thus, the release wire12332 secures the retaining arm 12320 to the outer prong 12330 until itis withdrawn (e.g., by a user at the proximal end of the support stentdelivery system). It should be understood that only a single outer prongand release are illustrated in FIG. 123 for illustrative purposes only.In actual implementations, additional outer prongs and release wires canbe included as part of the overall support stent delivery system (e.g.,the support stent delivery system can include three outer prongs andthree release wires releasably coupled to the support stent). In theillustrated embodiment, the release wire 12332 extends through sutures(including representative suture 12340) along a first frame member ofthe support stent and to a first valley 12310 of the support stent, andfurther extends across to a second adjacent valley 12312 and throughsutures (including representative suture 12342) along a second adjacentframe member of the support stent. In this way, the release wire forms aloop 12334 that extends below the bottom edge of the support stent 12300and that is located opposite of a respective peak 12314 of the supportstent. The release wire 12332 can be formed from a variety of differentmaterials, but in one embodiment is formed from a biocompatible metal oralloy. The release wire 12332 is desirably flexible enough to achievethe illustrated loop shape, but is also rigid enough to act as astabilizer arm that engages and resists the movement of a native heartvalve leaflet when the support stent 12300 is advanced into a positionadjacent to the outflow side of the heart valve.

In use, for example, when the support stent 12300 is deployed from asupport stent delivery system (such as any of the delivery systemsdescribed above) and advanced toward the outflow side of the aorticvalve, the loop 12334 can engage a native heart valve leaflet. As thesupport stent 12300 is advanced, the loop 12334 can press against theleaflet and suppress its movement during the patient's heart beat. Theloop 12334 can further be configured so that it is angled slightlyinwardly, so that when the loop deforms, it deforms inwardly into theinterior of the support stent 12300. Therefore, as the support stent12300 is advanced into position, the loop 12334 can operate to engageand urge the native leaflet inwardly, while also preventing the leafletfrom flapping open to the exterior of the support stent. Furthermore,the loop 12334 creates a wider area of contact against the nativeleaflets than the valleys of the support stent, making it more likelythat as the loop 12334 engages the leaflet and urges it inwardly, thecorresponding peaks and valleys of the support stent will be locatedradially outward of the leaflets, rather than straddling the nativeleaflet or being located radially inward of the native leaflets. Oncethe support stent 12300 is located in its desired position on the nativevalve, the release wire 12332 can be removed from the support stent(e.g., by an operator withdrawing the release wire at a proximal end ofthe support stent delivery system). This action removes the loop 12334,freeing the native leaflet it engaged, and releases the support stentfrom the delivery system. In some embodiments, the release wire 12332 iswithdrawn in at least two stages. In a first stage, for example, therelease wire 12332 can be withdrawn partially so that the loop 12334 isremoved but the support stent 12300 remains coupled to the prong 12330.A prosthetic valve can then be positioned into the interior of thesupport stent and expanded. In a second stage, the release wire 12332can be fully withdrawn, thereby releasing the support stent from theprong 12330.

For any of the leaflet stabilizing systems introduced above, it shouldbe understood that the leaflet stabilizing arms can be configured to beindividually controllable or controllable in different groupings.Further, any of the leaflet stabilizing arms can include relief cuts orsmall springs that allow the arms to achieve a desired flexibility.Additionally, the systems introduced above should not be construed aslimiting, as other leaflet stabilizing systems or mechanisms can be usedto aid in the delivery of a support stent. For example, a leafletstabilizing system that is configured to extend a wire lasso or otherclosed loop from its distal end can be used. The wire lasso or loop canbe shaped so that its diameter is large enough to surround at least aportion of the native valve leaflets when deployed. Once the wire lassosurrounds the native valve leaflets, the lasso can be partiallyretracted into the delivery system, thereby shrinking the size of theloop formed by the lasso and capturing the native valve leaflets intothe loop. The delivery system can then be retracted partially or movedas appropriate in order to hold the native leaflets in a stabilizedposition while the support stent is delivered. In another embodiment,the support stent delivery system (e.g., a transfemoral support stentdelivery system) is modified to include an inner catheter having adistal end attached to a disc or disc plunger. During delivery of thesupport stent, the disc can be advanced to engage the leaflets andconstrict the leaflets during stent delivery. In still anotherembodiment, the support stent delivery system (e.g., a transfemoralsupport stent delivery system) is modified to include an inner catheterfrom which three leaflet stabilizing arms can be deployed. The leafletstabilizing arms can have shapes similar to those described herein andcan initially extend outwardly to a large radius within the aorta. Onceadvanced to engage the native heart valve leaflets, the leafletstabilizing arms can be urged together (radially inwardly). This actioncan be performed, for example, by advancing a washer around the leafletstabilizing arms or advancing a sheath or catheter around the arms. As aresult of the leaflet stabilizing arms being drawn together, theleaflets are held in a stabilized position and the support stent can bedelivered more reliably to a position around the leaflets. Furthermore,for the systems described above with respect to FIGS. 110-122, theleaflet stabilizing arms can also operate to expand the pinch to adiameter larger than its natural diameter. This expansion further helpsthe support stent capture all of the leaflets of the native heart valve.Expansion of the support stent can also be performed using a ballooncatheter (e.g., delivered transapically or integrated into the supportstent delivery system) that can be expanded within the support stentbefore it is delivered onto the leaflets. Additionally, the leafletstabilizing arms of any of the embodiments described above can bereplaced with a wire basket formed from three wires. In certainimplementations, the wires are oriented to correspond to the locationsof the commissures of the aortic valve. In use, the wire basket can beurged through the aortic valve by aligning the wires with thecommissures. The native heart valve leaflets are thus at least partiallyenclosed within the distal portion of the wire basket. The support stentcan then be delivered and advanced onto the wire basket whereby thewires act as guide rails for the support stent.

Exemplary Embodiments of Support Stent Securing Mechanisms

FIGS. 124-139 illustrate various embodiments for the support stent thatcan be used together with any of the delivery systems described herein.In particular, the illustrated embodiments include mechanisms or meansfor further securing the support stent to a prosthetic heart valve(e.g., to the frame of a prosthetic heart valve). The disclosed securingmechanisms can be particularly useful securing the prosthetic heartvalve to the support stent and the native aortic valve during thediastolic phase of a patient's heart beat, which creates a greaterpressure differential than the systolic phase. The features shown insupport stents illustrated in FIGS. 124-139 can be used alone or invarious combination and subcombinations with one another as appropriate.Additionally, any of the features of the support stents illustrated inFIGS. 124-139 can be used in combination with any of the featuresdescribed in the other support stent embodiments disclosed herein. Forexample, any portion of the support stents described in this section canbe covered with a cloth or other biocompatible material as describedabove in order to reduce any sharp or hard edges in the design. Thesupport stents in FIGS. 124-139 can have a generally annular or toroidalbody formed from a suitable shape-memory metal or alloy, such as springsteel, Elgiloy®, or Nitinol. Desirably, the material from which thesupport stents are fabricated allows the support stent to automaticallyexpand to its functional size and shape when deployed but also allowsthe support stent to be radially compressed to a smaller profile fordelivery through the patient's vasculature. In other embodiments,however, the stent is not self expanding.

FIG. 124 illustrates a support stent in which one or more peaks includean inward-facing projection. In particular, FIG. 124 is a perspectiveview of support stent 12400, which includes six peaks and six valleys.It should be noted, however, that more or fewer peaks and valleys can beincluded in the support stent depending on the design. In theillustrated embodiment, projections 12410, 12412, 12414, 12416, 12418,12420 protrude inwardly from the apices of respective peaks 12430,12432, 12434. 12436, 12438, 12440. More of fewer projections can beincluded in the support stent design depending on the design. Theprojections 12410, 12412, 12414, 12416, 12418, 12420 are configured toextend slightly upwardly from their base. Furthermore, in certainembodiments, the projections 12410, 12412, 12414, 12416, 12418, 12420are configured to be bendable upon application of a sufficient force.The projections 12410, 12412, 12414, 12416, 12418, 12420 can be used tosecure the support stent 12400 to the frame of a prosthetic valve and tohelp prevent the undesired movement of the prosthetic valve. Inparticular, the projections 12410, 12412, 12414, 12416, 12418, 12420 areused to resist movement of the transcatheter heart valve into thepatient's left ventricle as a result of the pressure differentialcreated during the filling of the ventricle during the diastole phase.

FIG. 125 is a perspective view of the support stent 12400 engaged withthe frame of a prosthetic valve 12450. In particular, the projections12410, 12412, 12414, 12416, 12418, 12420 are positioned so that theyextend through the upper portion of diamond-shaped frame elements 12460,12462, 12464, 12466, 12468, 12470. The slightly upward trajectory of theprojections 12410, 12412, 12414, 12416, 12418, 12420 helps prevent theprosthetic valve 12450 from moving downward, thereby better securing theprosthetic valve within the interior of support stent 12400.

FIG. 126 is a side view of the support stent 12400 engaged with theframe of the prosthetic valve 12450 when the prosthetic valve is locatedin a patient's aortic valve. As explained above, the prosthetic valve12450 can be expanded within the aortic valve and the interior of thesupport stent 12400, thereby frictionally securing the prosthetic valve12450 into the valve by “pinching” the native valve leaflets (includingleaflets 12460, 12462) between the interior of the support stent 12400and the exterior of the frame of the prosthetic valve 12450. Projections12410, 12412, 12414, 12416 can extend through apertures in the upperportion of the frame of the prosthetic valve 12450 upon expansion of theprosthetic valve 12450, thereby creating a further mechanical engagementthat prevents the prosthetic valve 12450 from moving, or slipping, intothe left ventricle. In certain embodiments, the expanded prostheticvalve 12450 is moved upward (in the direction of the outflow side of thevalve) into the aortic valve while the support stent 12400 is held inplace by a support stent delivery system (e.g., any of the support stentdelivery systems described above). This action causes the top edge ofthe frame of the prosthetic valve 12450 to first bend the projections12410, 12412, 12414, 12416 and then cause the projections to “snap” backto their original position once the top edge of the frame passes theprojections, thereby securing the prosthetic valve to the support stentin the configuration shown in FIG. 126. In other words, the projectionsact as a “snap-fit” mechanism for securing the prosthetic valve to thesupport stent. In FIG. 126, the support stent 12400 is shown partiallycut away so that only the back half of the support stent 12400 isillustrated. It should be understood, however, that the front half ofthe support stent 12400 also surrounds the prosthetic valve 12450 andfurther includes projections for holding the support stent 12400 inplace.

The projections shown in FIG. 124 can be located at a variety ofdifferent positions on the support stent, including at or near theapices of the peaks of the support stent, near the middle of the supportstent, or at or near the bottom (or nadirs) of the valleys of thesupport stent. For example, FIG. 127 illustrates a support stent 12700similar to support stent 12400 in which three inward-facing, projections12710, 12712, 12714 are located at the apices of the peaks of thesupport stent. In particular, the projections 12710, 12712, 12714 arelocated at the apices of the peaks of the support stent that do not alsoinclude a retaining arm 12720, 12722, 12724. As with support stent12400, the projections 12710, 12712, 12714 are configured to extendslightly upwardly from their base. Furthermore, in certain embodiments,the projections 12710, 12712, 12714 are configured to be bendable uponapplication of a sufficient force. When engaged with a prosthetic valve(e.g., in a fashion similar to that shown in FIG. 125 or 126), theprojections 12710, 12712, 12714 resist movement of the transcatheterheart valve into the patient's left ventricle as a result of thepressure differential created during the filling of the ventricle duringthe diastole phase.

FIG. 128 illustrates another embodiment of a portion of a support stent12800 in which an inward-facing projection is formed along an edge ofthe support stent such that it can be bent into the cylindrical plane ofthe support stent. For example, in the embodiment illustrated in FIG.128, a projection 12810 is located at a bottom edge of an apex of a peak12812 of the support stent 12800. Furthermore, the projection 12810 islocated on a peak that additionally includes a retaining arm 12820. Asshown in FIG. 128, the retaining arm 12820 can be secured to a prong12830 of a support stent delivery system (e.g., any of the support stentdelivery systems described above) via a release wire 12832. In theillustrated embodiment, the release wire 12832 passes through sutures12840, 12842 secured on a first side of the peak 12812 and throughsutures 12844, 12846, 12848 secured on a second side of the peak 12812.The release wire 12832 thereby holds the first side of the peak 12812next to the second side of the peak, effectively compressing the twopeaks together. A distal end 12833 of the release wire 12832 isillustrated in FIG. 128. The proximal end (not shown) of the releasewire 12832 can run through a catheter of the support stent deliverysystem to a proximal end of the delivery system, where it can beretracted by an operator. As illustrated in FIG. 128, the release wire12832 also engages the projection 12810 on the inward-facing side of thesupport stent 12800, thereby holding the projection 12810 in thecylindrical (z-directional) plane of the support stent. When the releasewire 12832 is removed (e.g., by an operator of the support stentdelivery system retracting the release wire), the two peaks move apartinto their deployed configuration and the projection 12810 moves inwardand upward into the interior of the support stent, thereby forming aprojection similar to that illustrated in FIG. 127. By allowing theprojection 12810 to protrude inwardly only when the release wire isretracted, a prosthetic valve can be more easily placed andappropriately oriented within the support stent 12800 before the supportstent is secured to the prosthetic valve using projections such asprojection 12810. Once released, the projection 12810 can engage theprosthetic valve in a manner similar to that illustrated in FIGS. 125and 126, thereby helping to prevent the unwanted movement of theprosthetic valve into the ventricle. Furthermore, it is to be understoodthat the configuration illustrated in FIG. 128 (or a similarconfiguration) can be repeated along one or more other peaks of thesupport stent.

FIGS. 129 and 130 illustrate another mechanism for further securing asupport stent to a prosthetic valve, especially in order to prevent theprosthetic valve from moving or slipping into the patient's ventricleduring the diastolic phase of the patient's heartbeat. FIG. 129 is aside view of a portion of an exemplary support stent 12900 in aflattened state. In particular, FIG. 129 illustrates a peak 12910 andtwo adjacent valleys 12920, 12922 of a support stent 12900. Asillustrated by arrow 12930, the support stent has a first diameter (orwidth) at the valleys 12920, 12922 and, as illustrated by arrow 12932, asecond diameter (or width) at the peak 12910. In the illustratedembodiment, the first diameter is greater than the second diameter. Theincreased diameter or width can be just at the base of the valleys12920, 12922 or can increase gradually as the support stent transitionsfrom the peak 12910 and the valleys 12920, 12922. As a result of theincreased diameter (or width), the support stent 12900 is more resilientto bending at or near the valleys (or base) of the frame of the supportstent 12900. In other words, the support stent 12900 is more rigid, orinflexible, toward the lower half of the support stent, and is moreflexible toward the upper half of the support stent.

FIG. 130 is a schematic cross-sectional side view of a patient's aorticvalve in which the support stent 12900 surrounds a prosthetic heartvalve 12950 (shown in its entirety for illustrative purposes) andfrictionally secures native heart valve leaflets 12960, 12962 betweenthe support stent 12900 and the prosthetic heart valve. As illustratedin FIG. 130, when the prosthetic heart valve 12950 is expanded in theaortic valve and in the interior of the support stent 12900, the upperportion of the support stent flexes outwardly more than the lowerportion of the support stent. Thus, in certain embodiments, the supportstent 12900 has a smaller diameter at its bottom edge than it has at itupper edge (e.g., the support stent 12900 has a generally frustoconicalshape when deployed into an expanded state in the native valve). In theillustrated embodiment, the prosthetic heart valve 12950 also has asmaller diameter at its bottom edge than it has at its upper edge (e.g.,the prosthetic heart valve 12950 also has a generally frustoconicalshape). In particular implementations, the prosthetic heart valve 12950is specifically designed to function with a smaller diameter at itslower edge, although prosthetic heart valves that typically expand intovalves having a constant diameter can also be used. As a result of thecone-like shape of the support stent 12900 and the prosthetic heartvalve 12950, movement of the prosthetic heart valve into the patient'sleft ventricle is resisted during the diastolic phase of the patient'sheart beat, thus creating a more secure placement of the prostheticheart valve in the patient's aortic valve.

FIG. 131 illustrates a further embodiment of a support stent 13100 inwhich all or a portion of the interior surface of the support stent13100 includes a roughened, corrugated, or other surface comprisingmultiple ridges configured to engage and resist relative movement of anopposing surface. In particular, the support stent 13100 shown in FIG.131 includes multiple upwardly angled ridges (or teeth) 13110, 13112that engage native heart valve leaflets 13160, 13162 and press theleaflets against the exterior surface of prosthetic heart valve 13150.The native heart valve leaflets 13160, 13162 are typically thinleaflets, such that the leaflets are pressed into one or more of theapertures of the frame (e.g., diamond-shaped apertures of the frame) ofthe prosthetic heart valve 13150, thereby creating a secure, frictionalengagement of the support stent to the prosthetic heart valve 13150.This frictional engagement helps resist movement of the prosthetic heartvalve 13150 into the patient's left ventricle, especially during thediastolic phase of the patient's heart beat.

FIG. 132 is a perspective view illustrating a support stent 13200 inwhich one or more valleys of the support stent include longitudinal armsthat extend downward and include a protrusion, flange, or platformdesigned to engage a bottom edge of the frame of a prosthetic heartvalve. In particular, FIG. 132 is a perspective view of the supportstent 13200, which includes six peaks and six valleys. It should benoted, however, that more or fewer peaks and valleys can be included inthe support stent depending on the design. In the illustratedembodiment, longitudinal arms 13210, 13212, 13214 extend from the bottomedges of the nadirs of respective valleys 13220, 13222, 13224. In otherembodiments, however, the longitudinal arms extend downward from the topedges of the apices of respective peaks of the support stent (e.g., fromthe top edge of every other peak of a six-peak support stent) or fromthe bottom edges of the apices of the respective peaks (e.g., from thebottom edge of every other peak of a six-peak support stent). In suchembodiments, the longitudinal arms extend downward along the length ofthe exterior of the support stent to distal ends below the support stentat positions similar to the longitudinal arms 13210, 1312, 13214 of FIG.132.

The longitudinal arms 13210, 13212, 13214 of the illustrated embodimentinclude inward-facing protrusions 13230, 13232, 13234 configured toengage and support the frame of a prosthetic heart valve. Theprotrusions 13230, 13232, 13234 can have a variety of shapes andconfigurations, and in the illustrated embodiment have a general spoonshape. Furthermore, the protrusion 13230, 13232, 13234 can be fabricatedfrom the same material as the support stent 13200 or can be fabricatedusing a more rigid, or stronger, material than the support stent. Inpractice, the protrusions 13230, 13232, 13234 are used to secure thesupport stent 13200 to the frame of a prosthetic valve and to helpprevent the undesired movement of the prosthetic valve. In particular,the longitudinal arms 13210, 13212, 13214 and protrusions 13230, 13232,13234 operate to resist movement of the transcatheter heart valve intothe patient's left ventricle as a result of the pressure differentialcreated during the filling of the ventricle during the diastole phase.

FIG. 133 is a perspective view of the support stent 13200 engaged with aprosthetic heart valve 13250. In particular, the lower edge of the frameof the prosthetic heart valve 13250 is engaged with the protrusions13230, 13232, 13234. As a result of the protrusions 13230, 13232, 13234,the prosthetic heart valve cannot migrate or move downwardly beyond theprotrusions.

FIG. 134 is a bottom view of the support stent 13200 positioned in anative heart valve 13260. As illustrated, the protrusions 13230, 13232,13234 and portions of the longitudinal arms 13210, 13212, 13214 extendthrough the aortic valve and into the inflow side of the aortic valve.For example, the longitudinal arms 13210, 13212, 13214 can be orientedso that they extend through the aortic valve along the commissures ofthe native heart valve leaflets and generally at locations near oradjacent to the cusps of the native heart valve leaflets. As notedabove, the support stent 13200 and the protrusions 13230, 13232, 13234resist movement of the prosthetic heart valve into the left ventricle.

The longitudinal arms 13210, 13212, 13214 can provide additionaladvantages to the support stent 13200. For example, when delivering thesupport stent 13200, the support stent can be initially positioned inthe aortic valve so that the longitudinal arms 13210, 13212, 13214extend through the aortic valve (e.g., by pushing the longitudinal armsthrough the valve during the delivery process). When the protrusions13230, 13232, 13234 are located on the inflow side of the native aorticvalve, the protrusions help secure the support stent 13200 to the aorticvalve by preventing movement of the support stent upward into the aortaduring the systolic phase of the patient's heartbeat. Furthermore,because the support stent is delivered so that the support stentsurrounds the native heart valve leaflets, the peaks of the supportstent act to prevent movement of the support stent 13200 into the leftventricle. Consequently, the support stent 13200 is self secured intothe aortic valve. This configuration allows the support stent deliverysystem for the support stent 13200 to be removed from the patient'svasculature after delivery of the support stent. Consequently, thesupport stent can be delivered using a first delivery system (atransfemoral or transapical delivery system), and the prosthetic heartvalve can be delivered using a second delivery system (a transfemoral ortransapical delivery system) after the first delivery system is removedfrom the patient's vasculature.

The shape of the protrusions 13230, 13232, 13234 shown in FIG. 132should not be construed as limiting in any way, as a number of othershapes or configurations are possible that result in a support stentthat at least partially extends through the native heart valve, andthereby acts to secure itself to the native heart valve. For example,FIG. 135 is a perspective view of a support stent 13500 that includeslongitudinal arms 13510, 13512, 13514 coupled to a generally circularmember 13520. The circular member 13520 can include a flange (or one ormore flange members) that are configured to engage the lower edge of theframe of a prosthetic heart valve and resist movement of the prostheticheart valve relative to the support stent 13500. FIG. 136 is aperspective view of another embodiment of a support stent 13600 thatincludes longitudinal arms 13610, 13612, 13614 that end with respectivehook portions 13620, 13622, 13624. Each of the hook portions 13620,13622, 13624 includes two inwardly angled members that are configured toengage a bottom edge of a frame of a prosthetic heart valve and resistmovement into the patient's ventricle.

FIG. 137 is a side view of another embodiment of a support stent 13700flattened out to better illustrate its shape. In support stent 13700,one or more of the valleys of the support stent are configured to beextended valleys and to include a curved portion that forms aninward-facing protrusion that operates to engage a prosthetic heartvalve and resist movement of the heart valve. In the illustratedembodiment, for example, the support stent 13700 includes nine peaks(three of which include retaining arms 13740, 13742, 13744) and ninevalleys (three of which form extended portions 13710, 13712, 13714). Theextended portions 13710, 13712, 13714 are valleys of the support stent13700 that extend longitudinally further than the adjacent valleys. Theextended portions 13710, 13712, 13714 further include curved endportions 13720, 13722, 13724 that are configured to curve inwardly(e.g., toward the center of the support stent) when the support stent13700 is in its normal annular or toroidal configuration. The curved endportions 13720, 13722, 13724 are configured to function similar to theprotrusions 13230, 13232, 13234 described above and engage and resistdownward movement of a prosthetic heart valve that is frictionallysecured to the support stent 13700. Furthermore, the extended portions13710, 13712, 13714 are configured so that they can extend through theaortic valve at the commissures of the native heart valve leaflets andinto the inflow side of the aortic side. For example, the extendedportions 13710, 13712, 13714 can be positioned at locations near oradjacent to the cusps of the native heart valve leaflets. A prostheticheart valve can then be expanded into the interior of the support stentsuch that the prosthetic valve is adjacent to or engages the curved endportions 13720, 13722, 13724.

When delivering the support stent 13700, the extended portions 13710,13712, 13714 can be held together in a central location until the mainbody of the support stent is properly oriented and positioned. Theextended portions 13710, 13712, 13714 can then be released such thatthey extend downwardly into their desired positions. FIGS. 138 and 139illustrate exemplary support stent delivery systems 13800, 13900 fordelivering the support stent 13700 in this manner. For instance, supportstent delivery system 13800 includes a support stent delivery outercatheter 13810 having outer prongs 13812, 13814, 13816 that arereleaseably coupled to retaining arms 13740, 13742, 13744 via retainingwires 13813, 13815 (not visible), 13817, which can be withdrawn from theretaining arms in order to release the support stent. Also shown in FIG.138 is an inner catheter 13820 having an at least partially hollow nosecone 13822 in which the ends of extended portions 13710, 13712 (notvisible), 13714 are positioned. The nose cone 13822 is configured tohold the extended portions 13710, 13712, 13714 together within the nosecone. In use, the support stent delivery system 13800 can be used todeliver the support stent 13700 transfemorally. The nose cone 13822 canbe advanced through the aortic valve so that the main body portion ofthe support stent 13700 can be positioned adjacent to the outflow sideof the aortic valve and in an orientation that surrounds the nativevalve leaflets. Once the main body of the support stent 13700 isproperly positioned, the inner catheter 13820 can be advanced distallyrelative to the support stent outer catheter 13810, thereby causing theextended portions 13710, 13712, 13714 to be released from the nose coneand to extend into their natural state (e.g., to extend downwardly fromthe support stent 13700). In their deployed configuration, the extendedportions 13710, 13712, 13714 can extend through the aortic valve throughthe commissures between the native valve leaflets and at locations at ornear the cusps of the native valve leaflets. A prosthetic heart valvecan then be expanded into the native heart halve and can be frictionallysecured to the support stent 13700 as described above.

FIG. 139 shows another embodiment of a support stent delivery system13900 that is similar to the support stent delivery system 13800 butwhich uses a retaining wire or retaining catheter mechanism to releasethe extended portions 13710, 13712 (not visible), 13714 of the supportstent 13700. In particular, the support stent delivery system 13900includes an inner catheter 13920 through which a release wire or releaserod 13922 extended. Sutures (such as suture 13930) are located at ornear the distal end of the release wire or release rod 13922 and areused to connect the release wire or release rod 13922 to respectiveextended portions 13710, 13712, 13714. Consequently, the extendedportions 13710, 13712, 13714 are held to the release wire or release rod13922. To release the extended portions 13710, 13712, 13714, the releasewire or release rod 13922 can be retracted into the inner catheter13920, thereby removing the release wire or release rod 13922 from thesutures and allowing the extended portions to expand into their naturalstate.

Any of the embodiments shown in FIGS. 124-137 can also be implemented asa two-part design in which a support stent not having inward-facingprojections, extension portions, a specialized interior surface, or avaried diameter or thickness is coupled to a secondary frame thatincludes such features. For example, a secondary frame comprisingprojections, such as any of the projections described above orillustrated in FIGS. 124-128, can be implemented. The secondary framecan be an expandable frame and can further include a mechanism forsecuring itself to the interior of the original support stent (e.g.,using outward-facing projections, extension portions with outward-facingprojections, retaining arms, or other such mechanisms). In use, theoriginal support stent can be delivered to a position adjacent to ornear the outflow side of a patient's aortic valve. The secondary framecan then be delivered and expanded into the interior of the supportstent, thereby securing itself to the support stent and forming amodified two-part support stent that includes one or more of thefeatures introduced above for further securing the support stent to theprosthetic heart valve. A prosthetic heart valve can then be deliveredinto the interior of the two-part support stent and expanded such thatit frictionally engages the native heart valve leaflets against theinterior of the secondary frame and is further secured via the one ormore additional mechanisms (e.g., inward-facing projections, extensionportions having inward-facing projections, a specialized interiorsurface, or a varied diameter or thickness).

Further Support Stent Embodiments for Other Valve Configurations

The above embodiments are shown as being used in conjunction with aprosthetic heart valve having a generally constant diameter. It shouldbe understood, however, that any of the disclosed embodiments can beused in connection with prosthetic heart valves having other shapes.Furthermore, and as more fully discussed below, the shape of theprosthetic heart valve can affect the shape and configuration of thesupport stent.

For example, FIG. 140 illustrates a prosthetic heart valve 14000 thatcan be used with any of the support stents described above. Inparticular, FIG. 140 is a perspective view of a prosthetic aortic heartvalve 14010 that includes an expandable frame member, or stent, 14012that supports a flexible prosthetic leaflet section 14014. The valve14000 is radially compressible to a compressed state for deliverythrough the vasculature of a body to a deployment site and expandable toits functional size shown in FIG. 140 at the deployment site. In certainembodiments, the valve 14000 is self-expanding; that is, the valve canradially expand to its functional size when advanced from the distal endof a delivery system. In other embodiments, the valve can be aballoon-expandable valve that can be adapted to be mounted in acompressed state on the balloon of a delivery catheter. The illustratedvalve 14000 is adapted to be deployed in the native aortic annulus,although it also can be used to replace the other native valves of theheart. Moreover, the valve 14000 can be adapted to replace other valveswithin the body, such a venous valve.

The frame 14012 can be formed from a plurality of longitudinallyextending, generally sinusoidal shaped frame members, or struts, 14016.The struts 14016 are formed with alternating bends and are integrallyjoined (or otherwise secured to each other) at nodes 14018 formed fromthe vertices of adjacent bends so as to form a mesh structure. Thestruts 14016 can be made of a suitable shape memory material, such asthe nickel titanium alloy known as Nitinol, that allows the valve to becompressed to a reduced diameter for delivery in a delivery system andthen causes the valve to expand to its functional size inside thepatient's body when deployed from the delivery system.

The frame 14012 has an inflow end 14026 and an outflow end 14027. Themesh structure formed by struts 14016 comprises a generally cylindrical“upper” or outflow end portion 14020, an outwardly bowed or distendedintermediate section 14022, and an inwardly bowed “lower” or inflow endportion 14024. The intermediate section 14022 desirably is sized andshaped to extend into the Valsalva sinuses in the root of the aorta toassist in anchoring the valve in place once implanted. As shown, themesh structure desirably has a curved shape along its entire length thatgradually increases in diameter from the outflow end portion 14020 tothe intermediate section 14022, then gradually decreases in diameterfrom the intermediate section 14022 to a location on the inflow endportion 14024, and then gradually increases in diameter to form a flaredportion 14025 terminating at the inflow end 14026. The inflow endportion 14024 can therefore be said to have an hourglass shape below theoutwardly bowed intermediate section 14022. When the valve is in itsexpanded state, the intermediate section 14022 has a diameter D₁, theinflow end portion 14024 has a minimum diameter D₂, the inflow end 14026has a diameter D₃, and the outflow end portion 14020 has a diameter D₄,where D₂ is less than D₁ and D₃ and (optionally) D₄. In addition, D₁ andD₃ desirably are greater than the diameter than the native annulus inwhich the valve is to be implanted. In this manner, the overall shape ofthe stent 14012 assists in retaining the valve at the implantation site.Further embodiments and details of the support stent 14000 are describedin U.S. Patent Application Publication No. 2010/0049313 (U.S.application Ser. No. 12/429,040), which is hereby incorporated herein byreference.

FIGS. 141-148 illustrate various embodiments for a support stent thatcan be used together with any of the delivery systems described hereinand that can be used with the prosthetic heart valve 14000 or othersimilar prosthetic heart valves. In particular, the embodimentsillustrated in FIGS. 141-144 illustrate embodiments in which the frameof the support stent has a particular configuration or shape designed tobetter function with and complement a corresponding prosthetic heartvalve. Further, the embodiments illustrated in FIGS. 145-148 illustrateembodiments in which the frame of the support stent includes mechanismsfor engaging and securing (or retaining) the support stent to theprosthetic heart valve. The securing mechanisms shown in FIGS. 145-148can be particularly useful in securing the prosthetic heart valve to thesupport stent and the native aortic valve during the diastolic phase ofa patient's heart beat, which creates a greater pressure differentialthan the systolic phase. It should be understood that any of themechanisms introduced elsewhere in this disclosure for securing thesupport stent to the prosthetic valve (e.g., any of the mechanisms shownin FIGS. 124-139) can be used in various combinations andsubcombinations with embodiments shown in FIGS. 141-148 and vice versa.Furthermore, any portion of the support stent can be covered with acloth or other biocompatible material as described above in order toreduce any sharp or hard edges in the design. As with the other supportstents described herein, the support stents in FIGS. 141-148 can have agenerally annular or toroidal body formed from a suitable shape-memorymetal or alloy, such as spring steel, Elgiloy®, or Nitinol. Desirably,the material from which the support stents are fabricated allows thesupport stent to automatically expand to its functional size and shapewhen deployed but also allows the support stent to be radiallycompressed to a smaller profile for delivery through the patient'svasculature. In other embodiments, however, the stent is not selfexpanding.

FIG. 141 illustrates a support stent 14100 in which the frame of thesupport stent is shape set into an hourglass shape. In particular, FIG.141 is a perspective view of an hourglass-shaped support stent 14100that includes six peaks and six valleys. It should be noted, however,that more or fewer peaks and valleys can be included in the supportstent depending on the design. The hourglass shape of support stent14100 means that the diameter of the support stent at a central ormiddle portion 14110 is less than the diameter of the support stent at atop portion 14120 or bottom portion 14122. When a prosthetic valve suchas prosthetic valve 14000 is deployed within the support stent 14100 (orwhen a prosthetic valve having a constant or substantially constantdiameter is deployed within the support stent), the support stent 14100imparts more frictional force at the center or middle portion 14110 ofthe support stent than other portions, thereby creating an area ofincreased radial force. Because the prosthetic valve 14000 includes anintermediate portion 14022 with a large diameter, the frictional forcecan be relatively large at this portion of the prosthetic valve,creating a more secure fit between the support stent, the prostheticvalve, and the interposed native valve leaflets.

FIG. 142 illustrates a support stent 14200 in which the frame of thesupport stent is shape set into an at least partially outwardly bowed(or inverted hourglass) shape. In particular, FIG. 142 is a perspectiveview of an at least partially outwardly bowed support stent 14200 thatincludes six peaks and six valleys. It should be noted, however, thatmore or fewer peaks and valleys can be included in the support stentdepending on the design. In particular implementations, the shape isconfigured to at least partially complement the shape of the prostheticheart valve. For instance, an outwardly bowed portion 14210 of thesupport stent 14200 can be configured to complement the intermediatesection 14022 of the prosthetic heart valve 14000.

FIG. 143 is a schematic cross-sectional side view of a patient's aorticvalve in which the support stent 14200 surrounds a prosthetic heartvalve (illustrated as the prosthetic heart valve 14000, which is shownin its entirety for illustrative purposes) and frictionally securesnative heart valve leaflets 14360, 14362 between the support stent 14200and the prosthetic heart valve. As illustrated in FIG. 143, when theprosthetic heart valve 14000 is expanded in the aortic valve and in theinterior of the support stent 14200, the outwardly bowed portion 14210of the support stent complements at least a portion of the shape of theprosthetic heart valve, and in particular the intermediate portion 14022of the prosthetic heart valve above the flared end portion 14025. Withthe shape of the support stent being configured to at least partiallycomplement the prosthetic heart valve 14000, the frictional forcebetween the support stent, the prosthetic heart valve, and theinterposing native heart valves can be more evenly distributed.

FIG. 144 illustrates a perspective view illustrating a support stent14400 in which one or more valleys of the support stent are formed toinclude inward-facing protrusions or flanges. In particular, FIG. 144 isa perspective view of the support stent 14400, which includes six peaksand six valleys. It should be noted, however, that more or fewer peaksand valleys can be included in the support stent depending on thedesign. In the illustrated embodiment, protrusions 14410, 14412, 14414are formed from the tips of respective valleys 14420, 14422, 14424 beinginwardly shape set. In other words, one or more valleys of the supportstent are bent, or shaped (e.g., into a J-shape), so that they formprotrusions at their tips that bend radially inward. In FIG. 144, dashedlines show the protrusions in their natural, inward-facing state. Theinward-facing protrusions 14410, 14412, 14414 are configured to createincreased frictional engagement between the support stent 14400 and theprosthetic heart valve 14400 (or other prosthetic heart valve havingdiffering diameters) at a location of the prosthetic heart valve betweenthe minimum diameter D2 and the maximum diameter D1. For example, whenthe prosthetic heart valve 14000 is deployed within the support stent14400, the protrusions 14410, 14412, 14414 can create further radialforce against the prosthetic heart valve at a lower portion of theintermediate section 14022, or an upper portion of the inflow endportion 14024 (e.g., at a location in the hourglass-shaped section ofthe prosthetic heart valve). By increasing the frictional force againstthe frame of the prosthetic heart valve, the protrusions 14410, 14412,14414 can be used to help frictionally secure the support stent 14400 tothe frame of the prosthetic valve and help prevent the undesiredmovement of the prosthetic valve. In particular, the protrusions 14410,14412, 14414 operate to resist movement of the prosthetic heart valve(e.g., the prosthetic heart valve 14000) into the patient's leftventricle as a result of the pressure differential created during thefilling of the ventricle during the diastole phase.

The illustrated protrusions 14410, 14412, 14414 include respectiveapertures 14411, 14413, 14415 that can be used to selectively releasethe protrusions from an undeployed state to a deployed state. Forexample, in certain embodiments of the disclosed technology, theprotrusions 14410, 14412, 14414 can be held in an undeployed stateduring delivery of the support stent (e.g., in a state in which theprotrusions are held in the vertical (or cylindrical) plane or slightlyoutward of the vertical (or cylindrical) plane of the support stent, asshown in FIG. 144) by virtue of respective release wires being insertedthrough each of the apertures 14411, 14413, 14415. The release wires canbe positioned on the radially outward side of the support stent and canextend longitudinally into a delivery catheter of the support stentdelivery system (e.g., any of the support stent delivery systemsdisclosed herein). The release wires can extend through the supportstent delivery system to a proximal end of the system, where the wirescan be retracted by an operator. For example, the release wires can bewithdrawn from the apertures 14411, 14413, 14415 by an operatorretracting the release wires. Such retraction of the release wirescauses the wires to become disengaged from the apertures 14411, 14413,14415 and allows the protrusions 14410, 14412, 14414 to move to theirdeployed, inward-facing state (represented in dashed lines in FIG. 144).

FIG. 146 is a further embodiment of a support stent that can be used tofrictionally secure interposed native valve leaflets to a prostheticheart valve. In particular, FIG. 146 is a perspective view of supportstent 14600 that has a generally ring, or halo, shape. In contrast tothe support stents described herein that have a sinusoidally shapedframe, the support stent 14600 does not take the shape or profile of thecommisures or native valve leaflets into consideration. Nonetheless, thesupport stent 14600 can be used to engage and secure the native leafletsbetween the support stent and the exterior of the prosthetic heart valve(e.g., the prosthetic heart valve 14000). For example, the support stent14600 can be deployed to circumferentially surround a portion of theprosthetic heart valve 14000 (e.g., using any of the support stentdelivery systems disclosed herein). In particular, the support stent14600 can be deployed such that it engages any part of the outflow endportion 14020 of the prosthetic heart valve 14000. In other embodiments,the support stent 14600 can be deployed such that it engages the lowerpart of the intermediate portion 14022 or any part of the inflow endportion 14024 located on the outflow side of the aortic valve. In such alocation, the support stent 14600 is located beneath the largestdiameter D1 of the prosthetic heart valve 14000, and thus furtherprevents the prosthetic valve 14000 from moving into the patient's leftventricle during the high-pressure diastolic phase of the patient'sheart beat. In particular embodiments, the ring-shaped support stent14600 can be at least partially covered by a cloth or otherbiocompatible material. When the support stent 14600 is pushed onto theoutflow side of the native valve leaflets, the cloth or other materialcan help reduce or prevent any paravalvular leakage through the nativevalve leaflets.

FIG. 147 is a perspective view illustrating a support stent 14700 inwhich one or more valleys of the support stent are attached to sphericalmembers (or spherical protrusions) 14710, 14712, 14714. In particular,FIG. 147 is a perspective view of the support stent 14700, whichincludes six peaks and six valleys, but more or fewer peaks and valleyscan be included in the support stent depending on the design. In theillustrated embodiment, spherical members 14710, 14712, 14714 areattached to the bottom edge of respective valleys 14720, 14722, 14724(e.g., via a weld, adhesive, or other fastening mechanism). In otherembodiments, the spherical members 14710, 14712, 14714 are integrallyformed into the valleys 14720, 14722, 14724 during the support stentmanufacturing process. The spherical members 14710, 14712, 14714 areconfigured to create increased frictional engagement between the supportstent 14700 and the prosthetic heart valve 14000 (or other prostheticheart valve having differing diameters) at a location of the prostheticheart valve between the minimum diameter D2 and the maximum diameter D1.For example, when the prosthetic heart valve 14000 is deployed withinthe support stent 14700, the spherical members 14710, 14712, 14714 cancreate further radial force against the prosthetic heart valve at alower portion of the intermediate section 14022, or an upper portion ofthe inflow end portion 14024 (e.g., at a location in thehourglass-shaped section of the prosthetic heart valve where thediameter of the prosthetic heart valve increases in the direction towardthe outflow side of the valve). By increasing the frictional forceagainst the frame of the prosthetic heart valve, the spherical members14710, 14712, 14714 can be used to help frictionally secure the supportstent 14400 to the frame of the prosthetic valve and help prevent theundesired movement of the prosthetic valve. In particular, the sphericalmembers 14710, 14712, 14714 operate to resist movement of the prostheticheart valve (e.g., the prosthetic heart valve 14000) into the patient'sleft ventricle as a result of the pressure differential created duringthe filling of the ventricle during the diastole phase. The shape of thespherical members 14710, 14712, 14714 should not construed as limited,as differently shaped protrusions can extend from or be attached to abottom edge of one or more valleys of the support stent (e.g.,ellipsoidal protrusions, prong-shaped protrusions, hook-shapedprotrusions, and the like). The spherical members 14710, 14712, 14714(or other protrusions) can also be angled inwardly in order to createeven greater frictional force when engaged with a prosthetic heartvalve.

FIG. 145 is a schematic cross-sectional side view of a patient's aorticvalve in which the support stent 14700 surrounds a prosthetic heartvalve (illustrated as the prosthetic heart valve 14000, which is shownin its entirety for illustrative purposes) and frictionally securesnative heart valve leaflets 14560, 14562 between the support stent 14700and the prosthetic heart valve. In FIG. 145, the support stent 14700includes spherical member 14710 and a spherical member 14716 located atan opposite valley of the support stent. As can be seen in FIG. 145, thespherical members 14710, 14716 create a smaller diameter of the supportstent 14700 at a location of the prosthetic heart valve 14000 where thediameter of the prosthetic heart valve increases in the direction of theoutflow end of the prosthetic heart valve (e.g., between the maximumdiameter of the intermediate section 14022 and the minimum diameter ofthe inflow end portion 14024). Thus, the spherical members 14710, 14716create a larger radially inward force at their location, and furthersecure the prosthetic heart valve 14000 against undesired movement(e.g., movement into the left ventricle).

FIG. 148 is a perspective view illustrating a support stent 14800 inwhich the frame of the support stent includes one or more inward-facingprotrusions or prongs at locations between the peaks and valleys of theframe. In particular, FIG. 148 is a perspective view of the supportstent 14800, which includes six peaks and six valleys, but more or fewerpeaks and valleys can be included in the support stent depending on thedesign. In the illustrated embodiment, protrusions 14810, 14812, 14814extend from locations 14820, 14822, 14824 of the support stent framethat are between respective peaks and valleys of the support stent.Further, the protrusions 14810, 14812, 14814 are shape set to angleinwardly (shown in dashed lines in FIG. 148). The illustratedprotrusions 14810, 14812, 14814 include respective eyelets 14811, 14813,14815 that are oriented to provide a vertical aperture and that can beused to selectively release the protrusions from an undeployed state toa deployed state. For example, in certain embodiments of the disclosedtechnology and similar to the support stent 14400 illustrated in FIG.144, the protrusions 14810, 14812, 14814 can be held in an undeployedstate during delivery of the support stent (e.g., in a state in whichthe protrusions are held in the vertical (or cylindrical) plane orslightly outward of the vertical (or cylindrical) plane of the supportstent, as shown in FIG. 148) by virtue of respective release wires beinginserted through each of the eyelets 14811, 14813, 14815. When deployed,the inward-facing protrusions 14810, 14812, 14814 are configured toextend through apertures of and engage the frame of the prosthetic heartvalve (e.g., the frame of the prosthetic heart valve 14000 at locationsnear or adjacent to the intermediate section 14022 of prosthetic heartvalve) and thereby secure the support stent to the frame of theprosthetic valve and help prevent the undesired movement of theprosthetic valve (e.g., movement of the prosthetic heart valve duringthe diastolic phase of the patient's heart beat). The shape of theprotrusions 14810, 14812, 14814 can vary from implementation toimplementations. For example, the protrusions 14810, 14812, 14814 can berectangular, hook-shaped, L-shaped, dorsal-fin shaped, or have someother shape. Furthermore, the protrusions 14810, 14812, 14814 can beangled slightly upwardly in order to more effectively resist movement ofthe prosthetic heart valve into the patient's left ventricle.

Although the embodiments illustrated in FIGS. 144-148 illustrateretention mechanisms that are incorporated into the support stent, it isalso possible for retention mechanisms to be delivered to the supportstent and the prosthetic heart valve once they are deployed within apatient's heart valve. For example, FIG. 149 is a perspective viewillustrating one example of a mechanism for further securing a supportstent 14900 (illustrated as a support stent having six peaks and sixvalleys, although other numbers of peaks and valleys are possible) tothe frame of a prosthetic heart valve 14950 (which has the sameconfiguration as the prosthetic heart valve 14900). In the illustratedembodiment, the support stent 14900 includes three retaining arms 14910,14912, 14914, which can be used to position and deploy the support stentto the appropriate location on the outflow side of the patient's heartvalve using embodiments of the delivery systems described above. Theprosthetic heart valve 14950 also has three retaining arms 14960, 14962,14964, which can be used to position and deploy the prosthetic heartvalve using embodiments of the delivery systems described above orsystems described in U.S. Patent Application No. 2010/0049313 (U.S.application Ser. No. 12/429,040). In the illustrated embodiment, theretaining arms 14910, 14912, 14914 of the support stent 14900 areoriented so that they are adjacent to the retaining arms 14960, 14962,14964 of the prosthetic heart valve 14950. This orientation can beachieved during delivery of the support stent using appropriate imagingtechniques or by rotating the support stent until the operator feels theretaining arms 14910, 14912, 14914 “catch” or engage the retaining arms14960, 14962, 14964 of the prosthetic heart valve 14950. Using a varietyof mechanisms, the retaining arms 14910, 14912, 14914 of the supportstent can be secured to the retaining arms 14960, 14962, 14964 of theprosthetic heart valve 14950. For example, in the illustratedembodiment, respective clips 14920, 14922, 14924 (or other fasteners)are delivered to the adjacent pairs of retaining arms and secure thepairs together. In the particular embodiment illustrated in FIG. 149,clips 14920, 14922, 14924 are clips that are crimped in place by asuitable crimping catheter. In other embodiments, the clips can beformed of a shape-memory alloy that self compresses once deployed aroundthe respective pairs of retaining arms.

In other embodiments, the support stent is secured to the frame of theprosthetic heart valve prior to delivery. For example, any of thesupport stents can be secured to any of the prosthetic heart valveembodiments prior to deployment using any of the disclosed retentionmechanisms. For instance, a portion of the support stent can be securedto a portion of the prosthetic heart valve at the time the prostheticvalve is compressed and loaded into the delivery system. In suchembodiments, delivery of the support stent and the prosthetic heartvalve typically involves delivering the support stent and the prostheticheart valve using an integrated delivery system (such as any of theintegrated delivery systems described herein). Furthermore, delivery canbe performed in a multi-stage approach, whereby at least a portion ofthe support stent is expanded first, followed by expansion of theprosthetic heart valve.

FIG. 150 is a perspective view illustrating an example of delivering asupport stent that is at least partially locked to the prosthetic heartvalve prior to valve deployment. In particular, the delivery systemillustrated in FIG. 150 is similar to the delivery system describedabove with respect to FIGS. 56-61, but does not include a prostheticvalve sheath surrounding the prosthetic valve delivery catheters. Itshould be noted that the system illustrated in FIG. 150 is forillustrative purposes only, and other integrated delivery systems can beused. As shown in FIG. 150, the retaining arms of the support stent15010 are secured to corresponding retaining arms of the prostheticheart valve 15050 via one or more clips 15020, 15022, 15024. Duringdelivery, an outer sheath 15030 of the delivery system can be retracted,thereby allowing the unsecured ends of the support stent 15010 to expandradially outwardly. The support stent 15010 and the prosthetic heartvalve 15050 can then be advanced distally toward the native heart valve.To help properly position the native heart valve leaflets between theinterior of the support stent frame and the exterior of the prostheticheart valve 15050, a rapid pacing catheter (not shown) can be used toinduce a rapid heart beat, thereby causing the native leaflets to flapopen rapidly. With such rapid pacing, the support stent 15010 and theprosthetic heart valve 15050 can be advanced more reliably into theproper position (shown in FIG. 150). Furthermore, to help ensure thatthis position is maintained after deployment, inner prongs of supportstent delivery inner catheter 15032 and inner prongs of prosthetic heartvalve delivery inner catheter 15034 can be retracted during the rapidpacing, thereby allowing the retaining arms to be released from outerprongs of support stent delivery outer catheter 15042 and outer prongsof prosthetic heart valve delivery outer catheter 15044. The supportstent 15010 and the prosthetic heart valve 15050 can then expand intotheir deployed state while remaining secured to one another via theclips 15020, 15022, 15024. The delivery system illustrated in FIG. 150can be modified in a number of manners. For example, an extended hollownose cone that is configured to partially enclose the compressedprosthetic heart valve 15050 up to a point at or near the retaining armscan be used. During delivery, the extended hollow nose cone can helpmaintain the prosthetic heart valve in its compressed state and allowthe prosthetic heart valve to be reliably delivered to the interior ofthe native heart valves. The nose cone can then be advanced relative tothe prosthetic heart valve, thereby revealing the valve and allowing itto expand into its deployed state.

It should be noted that a rapid pacing catheter can be used inconjunction with any of the support stent delivery techniques disclosedherein. Such rapid pacing can help reliably position the native heartvalve leaflets into a position between the interior of the support stentand the exterior of the prosthetic heart valve by effectively forcingthe leaflets to flap open rapidly.

Exemplary Prosthetic Heart Valve Modifications

Any of the prosthetic heart valves described herein can also include oneor more mechanisms that help secure the prosthetic heart valve to thenative heart valve leaflets. These additional retaining mechanisms canbe integrally formed into the design of the prosthetic heart valve orcan be part of a frame or other component that is attached to theprosthetic heart valve prior to being loaded into the delivery system.The retaining mechanisms can be include one or more retaining arms orprongs that are formed to press against the exterior of the prostheticheart valve but which can be flexed outwardly from the prosthetic heartvalve during deployment in order to capture the native valve leaflets.Representative examples of prosthetic heart valves that include nativeleaflet capturing mechanisms are shown in FIGS. 151 and 152. Theseembodiments should not be construed as limiting, however, as a widevariety of mechanisms can be used with a wide variety of prostheticheart valves (e.g., any of the prosthetic heart valves describedherein).

FIG. 151 is a perspective view of an exemplary prosthetic heart valve15100 having a leaflet retaining mechanism. In particular, the exemplaryprosthetic heart valve 15100 has a configuration similar to that ofprosthetic heart valve 14000 but includes one or more leaflet retainingarms 15110, 15112, 15114. The leaflet retaining arms 15110, 15112, 15114are configured to have base portions that extend radially outwardly fromthe main body of the prosthetic heart valve 15100 and to have distal endportions 15120, 15122 (not shown), 15124 that are shaped to loop backtoward the main body so that the distal end portions press against themain body of the prosthetic heart valve. In the illustrated embodiment,the leaflet retaining arms 15110, 15112, 15114 extend outward from anedge of an outflow end portion 15102 of the prosthetic heart valve15100, though the leaflet retaining arms can extend from other portionsof the prosthetic heart valve. The leaflet retaining arms 15110, 15112,15114 can be formed, for example, from a shape memory alloy or otherflexible metal or metal alloy that is shape set into the desired shape.In the illustrated embodiment, the distal end portions 15120, 15122,15124 are shaped to have a larger surface area than the remainder of theretaining arms 15110, 15112, 15114. In particular, the illustratedembodiment comprises spoon-shaped distal end portions 15120, 15122,15124, though the distal end portions can have other shapes as well(e.g., a square shape, a diamond shape, a shape consistent with theremainder of the retaining arm, fork shape, and so on). In otherembodiments, the leaflet retaining arms 15110, 15112, 15114 are formedto have a much wider cross-section than illustrated, and form wings orflaps that arch outwardly and loop back to the main body of theprosthetic heart valve. Additionally, the distal end portions 15120,15122, 15124 can be at least partially covered with a cloth or otherbiocompatible material in order to reduce any trauma experienced by thenative valve leaflets when the leaflets are secured by the leafletretaining arms 15110, 15112, 15114. Furthermore, in the illustratedembodiment, the distal end portions 15120, 15122, 15124 include eyelets(or apertures) 15121, 15123 (not visible), 15125 that are configured toreceive respective retaining wires that can extend proximally throughthe prosthetic heart valve delivery system. The retaining wires (notshown) can be configured to hold the leaflet retaining arms 15110,15112, 15114 radially outward from the main body of the prosthetic heartvalve during the valve delivery procedure. Once the valve isappropriately positioned within the annulus of the patient's aorticvalve, the retaining wires can be retracted from the eyelets 15121,15123 (not visible), 15125 (e.g., by an operator withdrawing the wiresproximally), thereby releasing the leaflet retaining arms 15110, 15112,15114 and causing them to move toward their natural state, therebycapturing the native heart valve leaflets and pressing the nativeleaflets against the exterior of the body of the prosthetic heart valve15100. To help ensure that the native heart valve leaflets are properlydisposed on the exterior of the prosthetic heart valve 15100, a rapidpacing catheter can be used to stimulate the heart beat of the patientprior to the retaining arms 15110, 15112, 151141 being released. Inalternative embodiments, the distal end portions 15120, 15122, 15124include retaining arms configured to be secured to corresponding outerand inner prongs of the prosthetic heart valve delivery system (e.g., ina fashion similar to the embodiments described above, such as theembodiment illustrated in FIGS. 4-6).

FIG. 152 is a perspective view of another exemplary prosthetic heartvalve 15200 having a leaflet retaining mechanism. In particular, theexemplary prosthetic heart valve 15200 has a configuration similar tothat of prosthetic heart valve 14000 but includes one or more leafletretaining arms 15210, 15212. For instance, in the illustratedembodiment, the prosthetic heart valve 15200 has three leaflet retainingarms (one of which is not visible in FIG. 152), but more or fewerleaflet retaining arms can be present. The leaflet retaining arms 15210,15212 are configured to extend laterally across the frame of theprosthetic heart valve and to press against the frame of the prostheticheart valve 15200 along an intermediate portion 15202. This deployedstate of the leaflet retaining arms 15210, 15212 is shown in dashedlines in FIG. 152. In particular, the illustrated leaflet retaining arms15210, 15212 are formed to extend from or be attached to respectivenodes 15204, 15206 of the main body portion. The leaflet retaining arms15210, 15212 can be formed, for example, from a shape memory alloy orother flexible metal or metal alloy that is shape set into the desiredshape. In the illustrated embodiment, the leaflet retaining arms 15210,15212 have distal end portions 15220, 15222 that are shaped to have thesame width as the remainder of the retaining arms. The distal endportions 15220, 15222 can have other shapes, however, that create alarger surface area to contact a native valve leaflet (e.g., a spoonshape, a square shape, a diamond shape, a fork shape, and so on).Additionally, the distal end portions 15120, 15122 can be at leastpartially covered with a cloth or other biocompatible material in orderto reduce any trauma experienced by the native valve leaflets when theleaflets are secured by the retaining arms 15110, 15112. Furthermore,the distal end portions 15220, 15222, include eyelets (or apertures)15221, 15223 that are configured to receive respective retaining wiresthat can extend proximally through the prosthetic heart valve deliverysystem. The retaining wires (not shown) can be configured to hold theleaflet retaining arms 15210, 15212 radially outward from the main bodyof the prosthetic heart valve during the valve delivery procedure. FIG.152 illustrates the retaining arms 15210, 15212 being positioned in thispre-release or undeployed state, although the retaining wires forholding the arms in this state are not shown for ease of illustration.Once the valve is appropriately positioned within the annulus of thepatient's aortic valve and oriented so that the native valve leafletswill be captured by the retaining arms 15210, 15212, the retaining wirescan be retracted from the eyelets 15221, 15223 (e.g., by an operatorwithdrawing the wires proximally), thereby releasing the leafletretaining arms 15210, 15212 and causing them to swing inward and capturethe native heart valve leaflets against the exterior of the frame of theprosthetic heart valve 15200. To help ensure that the native heart valveleaflets are properly disposed on the exterior of the prosthetic heartvalve 15200, a rapid pacing catheter can be used to stimulate the heartbeat of the patient prior to the retaining arms 15210, 15212 beingreleased. In alternative embodiments, the distal end portions 15220,15222 include retaining arms configured to be secured to correspondingouter and inner prongs of the prosthetic heart valve delivery system(e.g., in a fashion similar to the embodiments described above, such asthe embodiment illustrated in FIGS. 4-6).

Exemplary Dual System Delivery Methods

In several of the embodiments described above in which support stentdelivery and prosthetic heart valve delivery are both performedtransfemorally or both performed transapically, an integrated system isused. In other embodiments, however, two separate delivery systems canbe used to at least partially simultaneously deliver the support stentand the prosthetic heart valve to the outflow side of the aortic arch.For illustrative purposes, such dual system approaches are describedwith respect to approaches that at least partially simultaneouslyapproach the outflow side of the aortic valve (e.g., through theascending aorta) and/or are simultaneously present in the ascendingaorta during at least part of the delivery process, although similartechniques can be used to deploy the support stent and the prostheticheart valve from the inflow side of the aortic valve.

When delivering the support stent and the prosthetic heart valvetransfemorally using two separate delivery systems, access to the aorticvalve can be obtained through different access routes or points. Forexample, the support stent delivery system can be delivered through theleft femoral artery while the prosthetic heart valve delivery system canbe delivered through the right femoral artery, or vice versa. In otherembodiments, the support stent delivery system can be delivered throughthe carotid artery (e.g., through the right carotid artery and into thebrachiocephalic artery or through the left carotid artery) or throughthe subclavian artery (e.g., through the right subclavian artery andinto the brachiocephalic artery or through the left subclavian artery)and toward the outflow side of the aortic valve while the prostheticheart valve delivery system can be delivered transfemorally (e.g.,through the left or right femoral artery), or vice versa. Using thecarotid or subsclavian arteries can provide a more direct approach tothe aortic valve than through a femoral artery over the aortic arch,thus making such an approach potentially more desirable for deliveringthe support stent or prosthetic heart valve.

When multiple delivery systems are used to deliver the support stent andthe prosthetic heart valve, additional modifications to either thesupport stent delivery system or the prosthetic heart valve deliverysystem may be made. For example, FIG. 153 illustrates one exemplarysystem and procedure for deploying the support stent and securing aprosthetic valve to the support stent using a multi-system approachwhere the multiple delivery systems are at least partiallysimultaneously advanced toward the outflow side of the aortic valve (orare sequentially advanced but are simultaneously present in the aorticarch for at least part of the delivery process). In particular, FIG. 153is a cross-sectional view through the left side of a patient's heartshowing acts performed in delivering a support stent 15301 from theoutflow side of the aortic valve.

FIG. 153 shows a main catheter 15302 of a support stent delivery system15300 as it is advanced into a position near the surface of the outflowside of the aortic valve 15310. The support stent delivery system 15300can be inserted through one of the femoral arteries of the patient orthrough one of the carotid or subclavian arteries and advanced into theaorta in the retrograde direction. FIG. 153 also shows a main catheter15352 of a prosthetic heart valve delivery system 15350. The prostheticvalve delivery system 15350 can be inserted through another one of thefemoral arteries of the patient or through the carotid or subclavianarteries (if the support stent delivery system 15300 is advancedtransfemorally) and also advanced into the aorta in the retrogradedirection. FIG. 153 additionally shows prongs (such as prong 15340) ofthe outer fork of a stent delivery outer catheter 15308 and prongs (suchas prong 15338) of the inner fork of a stent delivery inner catheter(not visible) coupled to respective retaining arms of the support stent15301. FIG. 153 further shows a prosthetic valve delivery catheter 15360(a balloon catheter in the illustrated embodiment), nose cone 15350, andguidewire 15380, which is shown as being extended through the aorticvalve 15310. In the illustrated embodiment, the prosthetic valvedelivery catheter 15360 is advanced to the point where a balloon portion15372 around which the prosthetic valve 15370 is compressed and nosecone 15350 are located adjacent to an inflow side of the native leafletsof the aortic valve. Furthermore, in FIG. 153, the main catheter 15302is withdrawn from the stent delivery outer catheter 15308, the stentdelivery inner catheter, and the support stent 15301, allowing thesupport stent to expand into its uncompressed, natural shape in aposition above the aortic valve 15310.

During delivery, and in certain exemplary embodiments, the support stentdelivery system 15300 is advanced into the aortic arch and the supportstent 15301 is advanced into position at or above the outflow side ofthe aortic valve (e.g., to a position on the outflow side of the aorticvalve or to a position between 0 and 50 mm from the aortic valve) beforethe prosthetic valve delivery system 15350 is advanced through aorticarch and/or before the prosthetic valve delivery catheter 15360 isadvanced through the aortic valve. In order for the prosthetic valvedelivery catheter 15360 to be advanced through the aortic valve asshown, the prongs (such as prong 15340) of the outer fork and the prongs(such as prong 15338) of the inner fork are desirably shaped so thatthey are bow-shaped and arch radially outward from the end of the maincatheter 15302. Together, the prongs can be said to form a globe-like orpumpkin-like shape. This shape increases the space between the prongs,and creates a sufficient opening through which the nose cone 15350,balloon portion 15372, prosthetic valve 15370, and prosthetic valvedelivery catheter 15360 can be advanced into the illustrated position.

Delivery of the support stent and the prosthetic heart valve cancontinue as described above (e.g., with respect to FIGS. 40-46) but withappropriate modification for two delivery systems.

It should be understood that the exemplary systems shown in FIG. 153 areby way of example and that any suitable support stent delivery systemdisclosed herein or suitable prosthetic heart valve delivery systemdisclosed herein can be used as part of a dual system delivery method.

As illustrated by the various delivery systems and approaches describedin this disclosure, there are many delivery options available to boththe patient and the physician for delivering a prosthetic heart valvesecured by a support stent. In order to determine which of the systemsand approaches is most suitable for a particular patient, the patientcan be screened. For example, the patient can be screened forvasculature tortuosity and/or apical integrity. Depending on the patientetiology, a transfemoral approach may be a more appropriate mode ofdelivering the devices, or vice versa.

Considerations for Material Selection

For any of the systems described herein, the materials from which thesupport stent and the prosthetic heart valve are manufactured can impactwhether and what type of additional retention mechanism is used. Forexample, in certain embodiments, if the support stent and the prostheticheart valve are both manufactured of a shape memory alloy (e.g.,Nitinol), then some form of additional retention mechanism is desirablyused unless one of the devices has a significantly stronger radial forcerelative to the other. In other embodiments, one of the support stent orthe prosthetic heart valve is manufactured from a stronger, lessflexible, material, such as cobalt-chromium or stainless steel, whereasthe other of the devices is manufactured of a more flexible material,such as a shape-memory alloy like Nitinol. In the case where theprosthetic heart valve is made of the more flexible material, thedictating shape of the combined system is the support stent. In the casewhere the prosthetic heart valve is made of the more rigid material,then the dictating shape of the combined system is the prosthetic heartvalve. In either case, the frictional forces between the two devices aregenerally greater than situations where both devices are manufactured ofthe more flexible material (e.g., Nitinol). Consequently, in someembodiments, the devices do not include a further retention mechanism.Instead, the prosthetic heart valve is secured within the native heartvalve only through the frictional engagement of the native heart valveleaflets and the support stent.

Further Examples of Prosthethic Heart Valve Embodiments

Particular examples of prosthetic heart valves that can be used inconnection with embodiments of the disclosed technology includetranscatheter heart valves (“THVs”) available from Edwards Lifesciences.For example, a suitable THV includes a THV having a cobalt-chromiumframe and that has a size of 23, 26, 29, or 31 mm OD (though other sizesare also possible). The 29 mm OD embodiment, for example, has a lengthof 19.3 mm and can be delivered with a 24 Fr. delivery system.

Other examples of suitable prosthetic valves include those described inU.S. Patent Application Publication No. 2010/0049313 (U.S. applicationSer. No. 12/429,040). Embodiments of such valves can be about 20 mm inlength and have a size of 23, 26, 29, or 31 mm OD (though other sizesare also possible). Such valves are similar to the prosthetic heartvalve shown in FIG. 140 and have an anatomically correct hour glassshape at its inflow end portion that allows for a better fit within theaortic annulus. The valve can be delivered using a variety of deliverysystems, including a 17 Fr. delivery system.

CONCLUSION

Having illustrated and described the principles of the disclosedtechnology, it will be apparent to those skilled in the art that thedisclosed embodiments can be modified in arrangement and detail withoutdeparting from such principles. For example, any of the apparatus,associated components, or methods described in connection with theintegrated delivery systems (e.g., the systems described in connectionwith FIGS. 40-70) can be used as part of a delivery system or methodthat involves a combination of a transapical approach and a transfemoralapproach. For example, any of the apparatus, associated components, ormethods described in connection with delivering a support stenttransfemorally can be used in combination with apparatus and methods fordelivering a prosthetic valve transapically or vice versa. In view ofthe many possible embodiments to which the principles of the disclosedtechnologies can be applied, it should be recognized that theillustrated embodiments are only preferred examples of the technologiesand should not be taken as limiting the scope of the invention. Rather,the scope of the invention is defined by the following claims and theirequivalents. We therefore claim all that comes within the scope andspirit of these claims.

What is claimed is:
 1. A method, comprising: advancing a self-expandablesupport structure and a self-expandable prosthetic heart valve into apatient's heart using a delivery apparatus and a transapical deliveryapproach, wherein the support structure and the prosthetic heart valveare in a radially compressed state; positioning the support structure onor adjacent a surface of an outflow side of the patient's native aorticvalve using the delivery apparatus; radially expanding the supportstructure from the compressed state to a fully expanded state, thesupport structure having a support-structure interior; positioning theprosthetic heart valve radially within the support-structure interiorand within the patient's native aortic valve using the deliveryapparatus; radially expanding the prosthetic heart valve from thecompressed state to an expanded state while the prosthetic heart valveis in the support-structure interior and while the support structure isin the fully expanded state; and releasing the support structure fromthe delivery apparatus after the prosthetic heart valve is radiallyexpanded.
 2. The method of claim 1, wherein the support structurecomprises first and second end portions, and the first and second endportions of the support structure are in the fully expanded state in theact of radially expanding the support structure, and wherein the act ofradially expanding the support structure occurs before the act ofradially expanding the prosthetic heart valve.
 3. The method of claim 1,wherein the support structure comprises a plurality of U-shaped portionsthat are connected together at apices of the U-shaped portions.
 4. Themethod of claim 3, wherein the support structure includes a plurality ofretaining arms extending from the apices of the U-shaped portions. 5.The method of claim 4, wherein the delivery apparatus comprises aplurality of flexible arms that are releasably coupled to the retainingarms of the support structure.
 6. The method of claim 4, wherein theretaining arms comprise attachment apertures.
 7. The method of claim 3,wherein the delivery apparatus comprises a plurality of flexible armsthat are releasably coupled to the support structure during the acts ofadvancing the support structure and the prosthetic heart valve,positioning the support structure and the prosthetic heart valve, andradially expanding the support structure, and the flexible arms arereleased from the support structure after the prosthetic heart valve isradially expanded.
 8. The method of claim 1, wherein the supportstructure and the prosthetic heart valve are axially spaced relative toeach other along the delivery apparatus in the act of advancing thesupport structure and the prosthetic heart valve.
 9. The method of claim1, further comprising inserting a tube into a left ventricle of thepatient's heart, and the act of advancing the support structure and theprosthetic heart valve comprises inserting the support structure and theprosthetic heart valve through the tube using the delivery apparatus.10. The method of claim 1, wherein the act of radially expanding theprosthetic heart valve causes one or more native leaflets of the nativeaortic valve to be frictionally secured between the support structureand the prosthetic heart valve.
 11. A method, comprising: advancing anexpandable support structure and an expandable prosthetic heart valveinto a patient's heart using a single delivery apparatus, wherein thesupport structure and the prosthetic heart valve are in a radiallycompressed state; positioning the support structure on or adjacent asurface of an outflow side of a native heart valve of the patient usingthe delivery apparatus; radially expanding the support structure fromthe compressed state to a fully expanded state, the support structurehaving a support-structure interior, wherein the support structure isself-expandable; positioning the prosthetic heart valve radially withinthe support-structure interior and within the patient's native heartvalve using the delivery apparatus; and radially expanding theprosthetic heart valve from the compressed state to an expanded statewhile the prosthetic heart valve is in the support-structure interiorand while the support structure is in the fully expanded state, whereinthe prosthetic heart valve is self-expandable, and wherein the act ofradially expanding the prosthetic heart valve causes one or more nativeleaflets of the native heart valve to be captured between the supportstructure and the prosthetic heart valve.
 12. The method of claim 11,wherein the support structure comprises first and second end portions,and the first and second end portions of the support structure are inthe fully expanded state in the act of radially expanding the supportstructure, and wherein the act of radially expanding the prostheticheart valve occurs after the act of radially expanding the supportstructure.
 13. The method of claim 11, wherein the support structurecomprises a plurality of U-shaped portions that are connected togetherat apices of the U-shaped portions.
 14. The method of claim 11, whereinthe patient's native heart valve is a native aortic valve, and thesupport structure and the prosthetic heart valve are advanced into thepatient's heart transapically.
 15. The method of claim 11, wherein thepatient's native heart valve is a native aortic valve, and the supportstructure and the prosthetic heart valve are advanced into the patient'sheart transfemorally.
 16. A method, comprising: advancing a deliveryapparatus into a patient's heart, wherein an expandable supportstructure and an expandable prosthetic heart valve are mounted atspaced-apart locations along a distal end portion of the deliveryapparatus in a radially compressed state, wherein the support structureand the prosthetic heart valve are self-expandable and are advancedtogether in the same direction toward the patient's heart on thedelivery apparatus; positioning the support structure at or adjacent anative heart valve of the patient using the delivery apparatus; radiallyexpanding the support structure from the compressed state to a fullyexpanded state, wherein the support structure remains coupled to thedelivery apparatus after the support structure is expanded; positioningthe prosthetic heart valve radially within the support structure andwithin the patient's native heart valve using the delivery apparatus;radially expanding the prosthetic heart valve from the compressed stateto an expanded state while the prosthetic heart valve is radially withinthe support structure and while the support structure is in the fullyexpanded state; and releasing the support structure from the deliveryapparatus after the prosthetic heart valve is radially expanded.
 17. Themethod of claim 16, wherein the support structure comprises a first endportion and a second end portion, and the first end portion and thesecond end portion of the support structure are in the fully expandedstate in the act of radially expanding the support structure and beforethe act of radially expanding the prosthetic heart valve.
 18. The methodof claim 16, wherein the delivery apparatus comprises a first sheath anda second sheath, wherein the first sheath is configured to retain thesupport structure in the radially compressed state when the supportstructure is disposed radially within the first sheath, and the supportstructure is disposed radially within the first sheath in the act ofadvancing the delivery apparatus and in the act of positioning thesupport structure, and wherein the second sheath is configured to retainthe prosthetic heart valve in the radially compressed state when theprosthetic heart valve is disposed radially within the second sheath,and the prosthetic heart valve is disposed within the second sheath inthe act of advancing the delivery apparatus, in the act of positioningthe support structure, and in the act of radially expanding the supportstructure.
 19. The method of claim 18, wherein the act of radiallyexpanding the support structure includes relative axial movement betweenthe first sheath and the support structure to expose the supportstructure from the first sheath, and the act of radially expanding theprosthetic heart valve includes relative axial movement between thesecond sheath and the prosthetic heart valve to expose the prostheticheart valve from the second sheath.
 20. The method of claim 16, whereinone or more native leaflets of the patient's native heart valve arecaptured between the support structure and the prosthetic heart valvewhen the support structure is in the fully expanded state and theprosthetic heart valve is in the expanded state.